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A Phase II/III Trial of Neoadjuvant FOLFOX, With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Phase II/III Trial of Neoadjuvant FOLFOX, With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision


OBJECTIVES:

Primary

- To assure that neoadjuvant oxaliplatin, leucovorin calcium, and fluorouracil (FOLFOX)
followed by selective use of combined modality therapy with fluorouracil (5FUCMT) group
(Group 1) maintains the current high rate of pelvic R0 resection and is consistent with
non-inferiority for time to local recurrence (TLR). (Phase II)

- To compare neoadjuvant FOLFOX followed by Selective use of 5FUCMT (Group 1) to standard
5FUCMT (Group 2) with respect to the proportion of patients who achieve a pathologic
complete response (pCR) at the time of surgical resection. (Phase III)

- To compare bowel function in patients randomized to the neoadjuvant FOLFOX followed by
selective use of 5FUCMT vs standard 5FUCMT at approximately 1 and 2 years
postoperatively.

- To evaluate the feasibility of implementing the PRO-CTCAE in an NCI-sponsored treatment
trial.

- To evaluate the feasibility of implementing the PRO-CTCAE at Alliance sites.

- To evaluate the feasibility of patients self-reporting symptoms during treatment by
using the PRO-CTCAE.

- To prospectively use Molecular Inversion Probe (MIP) array technology and MALDI-TOF
mass spectrometry-based genotyping to identify copy number aberrations and somatic
mutations that mediate tumor formation using formalin-fixed, paraffin-embedded (FFPE)
tumor tissue from patients participating in the current study.

- To determine whether germline genetic variants in candidate genes of interest are
associated with response and/or toxicity to platinum and 5FU-based chemotherapy.

Secondary

- To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is
non-inferior to the standard group 5FUCMT (Group 2) with respect to the proportion of
patients who achieve a pCR at the time of surgical resection.

- To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is
non-inferior to the standard 5FUCMT (Group 2) with respect to overall survival.

- To evaluate and compare the adverse event profile and surgery complications between the
two groups.

- To estimate the proportion of patients in the selective group (Group 1) who receive
pre-operative 5FUCMT, post-operative 5FUCMT, and either pre- or post-operative 5FUCMT.

- To compare sexual function separately within men and within women between groups at
approximately 1 and 2 years post-operatively.

- To compare bladder function between groups at approximately 1 and 2 years
post-operatively.

- To compare health-related quality of life between groups at 1 and 2 years
post-operatively.

- To assess the correlation between bladder, bowel, and sexual function and quality of
life. (Exploratory)

- To investigate factors associated with bladder, bowel, and sexual dysfunction.
(Exploratory)

- To compare bladder and bowel function over time between genders. (Exploratory)

- To perform subgroup analyses based on other sociodemographic factors. (Exploratory)

- To evaluate and compare patients' self-reported symptom burden during treatment between
groups using the PRO-CTCAE system.

- To evaluate whether exposure to patient-reported symptoms influences CTCAE symptom
reporting by research staff. (Exploratory)

- To correlate the MIP array copy number and mutational data from patients with locally
advanced rectal cancer with clinical outcome in each treatment cohort (the clinical
outcomes include pathologic complete response, time to recurrence, time to pelvic
recurrence, and overall survival).

- To identify immune markers for response to neoadjuvant chemotherapy or chemoradiation
using very well-established, validated immunologic assays.

- To investigate the ability of neoadjuvant FOLFOX or chemoradiation to augment
anti-tumor immunity against rectal cancer.

- To identify novel immune targets in rectal cancer.

- To determine whether germline genetic variants in candidate genes of interest are
associated with response and/or toxicity to radiation therapy.

- To assess whether genetic-risk variants identified in genome-wide association studies
of colorectal cancer susceptibility are associated with rectal cancer clinical outcome
and response to therapy.

OUTLINE: This is a multicenter, phase II study followed by a phase III study. Patients are
stratified according to ECOG performance status (0 or 1 vs 2). Patients are randomized to 1
of 2 treatment arms.

- Group 1 (FOLFOX): Patients receive neoadjuvant chemotherapy comprising oxaliplatin IV
over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV
continuously on days 1-2. Treatment repeats every 14 days for 6 courses in the absence
of disease progression or unacceptable toxicity. Patients with at least 20% of tumor
regression undergo low-anterior resection (LAR) with total mesorectal excision (TME).
Patients with less than 20% of tumor regression undergo chemoradiation as in group 1
before proceeding to LAR with TME.

- Group 2 (5FUCMT): Patients receive fluorouracil IV continuously 7 days a week for 5.5
weeks or capecitabine orally (PO) twice daily (BID) 5 days a week for 5.5 weeks.
Patients also undergo 3-dimensional conformal or intensity-modulated radiation therapy
5 days a week for approximately 5.5 weeks. Patients then undergo LAR with TME.

Patients in both groups may receive adjuvant chemotherapy comprising FOLFOX and/or 5FUCMT.

Patients undergo blood sample collection at baseline and periodically during study for
genotyping and immunologic studies. Paraffin-embedded tissue samples from primary tumor are
also collected for aberration and somatic mutation studies by molecular inversion probe
(MIP) array and mass spectrometry-based genotyping.

Patients complete the Bowel Function Index, the Prostate Health-Related Quality-of-Life
(QOL) and the International Prostate Symptom Score (IPSS) questionnaires, the EuroQOL5D-5L
(EQ5D) questionnaire, and the International Index of Erectile Function (IIEF) or Female
Sexual Function Index (FSFI) questionnaire at baseline, and periodically during study.

After completion of study treatment, patient are followed up for up to 8 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of rectal adenocarcinoma

- Radiologically measurable or clinically evaluable disease

- For this patient, the standard treatment recommendation in the absence of a clinical
trial would be combined-modality, neoadjuvant chemoradiation followed by
curative-intent surgical resection

- Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy
according to the primary surgeon

- No patient for whom primary surgeon indicates need for abdominoperineal (APR) at
baseline

- Clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB)

- Clinical staging should be estimated based on the combination of the following
assessments: physical exam by the primary surgeon, CT scan of the
chest/abdomen/pelvis, and either a pelvic MRI or an ultrasound (ERUS)

- Clinical stage N2 disease is to be estimated as four or more lymph nodes
that are ≥ 10 mm

- No clinical T4 tumors

- Preoperative proctoscopy with tumor tissue evident between 5 and 12 cm from the anal
verge, inclusive

- No evidence that tumor is adjacent to (defined as within 3 mm of) the mesorectal
fascia on pre-operative MRI or ERUS/pelvic CT scan

- No tumor causing symptomatic bowel obstruction

PATIENT CHARACTERISTICS:

- ECOG performance status 0, 1, or 2

- Absolute neutrophil count (ANC) ≥ 1,500/mm³

- Platelets ≥ 100,000/mm³

- Hemoglobin > 8.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 3 times ULN

- Creatinine ≤ 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Patient of child-bearing potential is willing to employ adequate contraception

- Willing to return to enrolling medical site for all study assessments

- No other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic
polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix

- No co-morbid illnesses or other concurrent disease that, in the judgment of the
clinician obtaining informed consent, would make the patient inappropriate for entry
into this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No chemotherapy within 5 years prior to registration (hormonal therapy is allowable
if the disease-free interval is ≥ 5 years)

- No prior pelvic radiation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pelvic R0 resection rate (Phase II)

Outcome Time Frame:

Up to 18 weeks

Safety Issue:

No

Principal Investigator

Deborah Schrag, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

N1048

NCT ID:

NCT01515787

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IIA rectal cancer
  • stage IIIA rectal cancer
  • stage IIIB rectal cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Washington University School of MedicineSaint Louis, Missouri  63110
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
MeritCare BemidjiBemidji, Minnesota  56601
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
MeritCare BroadwayFargo, North Dakota  58122
CCOP - MeritCare HospitalFargo, North Dakota  58122
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Marshfield ClinicMarshfield, Wisconsin  54449
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
LDS HospitalSalt Lake City, Utah  84143
Hinsdale, Illinois  60521
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Peninsula Regional Medical CenterSalisbury, Maryland  21801
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Wesley Medical CenterWichita, Kansas  67214
Scott and White Memorial HospitalTemple, Texas  76508
Weill Medical College of Cornell UniversityNew York, New York  10021
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Mount Sinai Medical CenterNew York, New York  10029
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Maimonides Cancer Center at Maimonides Medical CenterBrooklyn, New York  11219
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Hematology and Oncology AssociatesChicago, Illinois  60611
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Massachusetts General HospitalBoston, Massachusetts  02114-2617
St. Anthony Central HospitalDenver, Colorado  80204-1335
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Palo Alto Medical FoundationPalo Alto, California  94301
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Stanford Cancer CenterStanford, California  94305-5824
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
John B. Amos Cancer CenterColumbus, Georgia  31904
Evanston HospitalEvanston, Illinois  60201-1781
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Grant Medical Center Cancer CareColumbus, Ohio  43215
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Oncology Alliance, SC - Milwaukee - WestWauwatosa, Wisconsin  53226
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
Temple University HospitalPhiladelphia, Pennsylvania  19140
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Easton Regional Cancer Center at Easton HospitalEaston, Pennsylvania  18042
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Kinston Medical SpecialistsKinston, North Carolina  28501
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Berkshire Hematology Oncology, PCPittsfield, Massachusetts  01201
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Case Western Reserve UniversityCleveland, Ohio  44106
Emory UniversityAtlanta, Georgia  30322
Saint Mary's Regional Medical CenterReno, Nevada  89503
Provena St. Mary's Regional Cancer Center - KankakeeKankakee, Illinois  60901
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Camino Medical Group - Treatment CenterMountain View, California  94040
Northwest Cancer Specialists at Vancouver Cancer CenterVancouver, Washington  98684
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Norwalk HospitalNorwalk, Connecticut  06856
Southeast Cancer CenterCape Girardeau, Missouri  63703
Goldschmidt Cancer CenterJefferson City, Missouri  65109
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Willamette Falls HospitalOregon City, Oregon  97045
Littleton Adventist HospitalLittleton, Colorado  80122
Roger Maris Cancer Center at MeritCare HospitalFargo, North Dakota  58122
Dyson Center for Cancer Care at Vassar Brothers Medical CenterPoughkeepsie, New York  12601-3990
Kaiser Permanente-OaklandOakland, California  94611
Kaiser Permanente-Redwood CityRedwood City, California  94063
Kaiser Permanente-RichmondRichmond, California  94801
Kaiser Permanente-RosevilleRoseville, California  95661
Kaiser Permanente-South SacramentoSacramento, California  95823
Kaiser Permanente - SacramentoSacramento, California  95825
Kaiser Permanente-San FranciscoSan Francisco, California  94115
Kaiser Permanente-Santa Teresa-San JoseSan Jose, California  95119
Kaiser Permanente-San RafaelSan Rafael, California  94903
Kaiser Permanente-Santa RosaSanta Rosa, California  95403
Kaiser Permanente-South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente-StocktonStockton, California  95210
Kaiser Permanente-VallejoVallejo, California  94589
Kaiser Permanente-Walnut CreekWalnut Creek, California  94596
Allegiance HealthJackson, Michigan  49201
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Saint Cloud HospitalSaint Cloud, Minnesota  56303
Sacred Heart HospitalEau Claire, Wisconsin  54701
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake CenterRice Lake, Wisconsin  54868
Marshfield Clinic-Wausau CenterWausau, Wisconsin  54401
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Southern Ohio Medical Center Cancer CenterPortsmouth, Ohio  45662
University of IllinoisChicago, Illinois  60612
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
John Muir Medical Center-Concord CampusConcord, California  94520
Spector, David MD (UIA Investigator)Moline, Illinois  61265
Providence Regional Cancer PartnershipEverett, Washington  98201
St. Francis Hospital Cancer Care ServicesIndianapolis, Indiana  46237
Mercy Clinic Cancer and Hematology - RollaRolla, Missouri  65401
Fox Chase Cancer Center BuckinghamFurlong, Pennsylvania  18925
Swedish Medical Center - Issaquah CampusIssaquah, Washington  98029
Memorial Sloan-Kettering Cancer Center - Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center - Rockville CentreRockville Centre, New York  11570
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical CenterMilford, Massachusetts  01757
Mercy Cancer Center - West LakesClive, Iowa  50325
Methodist West HospitalWest Des Moines, Iowa  50266-7700
Zangmeister CenterColumbus, Ohio  43219
Mercy-SpringfieldSpringfield, Missouri  65804
University of California Davis-Cancer CenterSacramento, California  95817
Dana-Farber/Brigham and Women's Cancer Center at South ShoreSouth Weymouth, Massachusetts  02190
Emory University Hospital MidtownAtlanta, Georgia  30308
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Norris Cotton Cancer Center-NorthSaint Johnsbury, Vermont  05819
Benefis Sletten Cancer InstituteGreat Falls, Montana  59405
Saint Clare's HospitalWeston, Wisconsin  54476
Presence Saint Mary's HospitalKankakee, Illinois  60901
Marshfield Clinic Cancer Center at Sacred HeartEau Claire, Wisconsin  54701
Central Vermont Medical Center/National Life Cancer TreatmentBerlin, Vermont  05602
Kaiser Permanente HaywardHayward, California  94545
Oakwood Healthcare IncDearborn, Michigan  48124
Mercy Hospital Saint LouisSaint Louis, Missouri  63141
Summa Akron City Hospital/Cooper Cancer CenterAkron, Ohio  44304
Western Oncology Research ConsortiumPortland, Oregon  97213