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A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal


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

Thank you

Trial Information

A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal


OBJECTIVES:

Primary

- Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil,
and mitomycin C decreases the combined rate of gastrointestinal and genitourinary
adverse events (grade II or greater) by at least 15% in the first 90 days after the
start of treatment in patients with primary invasive carcinoma of the anal canal
compared to patients treated on the radiotherapy, fluorouracil, and mitomycin C arm on
clinical trial RTOG 98-11.

Secondary

- Determine the feasibility of performing IMRT in these patients in a cooperative group
setting.

- Evaluate adverse events experienced by patients treated with this regimen and to
decrease the grade 2 and higher and grade 3 and higher overall adverse event rates by
15% or 20% as compared to the radiotherapy and mitomycin C arm of RTOG 98-11.

- Evaluate the total duration of radiotherapy.

- Evaluate the efficacy of this regimen, in terms of locoregional failure, disease-free
survival, time to colostomy, colostomy-free survival, and overall survival of these
patients.

- Determine clinical complete response at 8 weeks after completion of study treatment.

OUTLINE: This is a multicenter study.

Patients receive mitomycin C IV over 10-30 minutes on days 1 and 29 and fluorouracil IV
continuously over 96 hours on days 1-4 and 29-32. Patients also undergo dose-painted
intensity-modulated radiation therapy once daily, 5 days a week, for 5½ to 6 weeks beginning
on day 1. Treatment continues in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed carcinoma of the anal canal, including any of the following
subtypes:

- Squamous cell

- Basaloid

- Cloacogenic

- Primary invasive disease

- T2-4, N0-3 disease

- Clinically positive small inguinal nodes (i.e., < 1 cm in size) must be
confirmed by biopsy (preferably fine-needle aspiration) within the past 6 weeks

- Biopsy is not required for enlarged inguinal, perirectal, or pelvic nodes on
exam or CT scan that are found to be ≥ 1.0 cm and are considered to be
clinically positive

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

- ALT and AST < 3 times upper limit of normal

- Absolute neutrophil count ≥ 1,800/mm³

- Serum creatinine ≤ 1.5 mg/dL

- Platelet count ≥ 100,000/mm³

- Bilirubin < 1.4 mg/dL

- WBC ≥ 3,000/mm³

- INR ≤ 1.5

- No known AIDS

- HIV-positive patients without AIDS are eligible

- HIV test required for patients with clinical suspicion of AIDS

- No other invasive malignancy within the past 3 years except for nonmelanomatous skin
cancer

- No severe, active comorbidity, defined as any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study treatment

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Uncontrolled diabetes mellitus, uncompensated heart disease, and/or uncontrolled
high blood pressure, that in the opinion of the patient's treating physician,
requires an immediate change in management

- Patients may be eligible if appropriate changes in management have resulted
in adequate control of the above mentioned conditions

- Other immunocompromised status (e.g., organ transplantation or chronic
glucocorticoid use)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radiation therapy to the pelvis that would result in overlap of radiation
therapy fields

- No prior systemic chemotherapy for cancer of the anus

- No prior surgery for cancer of the anus that removed all macroscopic anal cancer

- No concurrent sargramostim (GM-CSF)

- No concurrent amifostine

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)

Outcome Time Frame:

From the start of treatment to 90 days

Safety Issue:

Yes

Principal Investigator

Lisa A. Kachnic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000524057

NCT ID:

NCT00423293

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Anal Cancer
  • stage II anal cancer
  • stage IIIA anal cancer
  • stage IIIB anal cancer
  • basaloid carcinoma of the anus
  • cloacogenic carcinoma of the anus
  • squamous cell carcinoma of the anus
  • Anus Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
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
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Northwest Community HospitalArlington Heights, Illinois  60005
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
LDS HospitalSalt Lake City, Utah  84143
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community HospitalBoca Raton, Florida  33486
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Piedmont HospitalAtlanta, Georgia  30309
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Wayne Radiation OncologyGoldsboro, North Carolina  27534
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
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
St. Francis HospitalFederal Way, Washington  98003
Cascade Cancer Center at Evergreen Hospital Medical CenterKirkland, Washington  98034-3013
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
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
Frederick R. and Betty M. Smith Cancer Treatment CenterSparta, New Jersey  07871
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
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
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Wilmed Radiation Oncology ServicesWilson, North Carolina  27893
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Solano Radiation Oncology CenterVacaville, California  95687
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Baptist Medical Center SouthJascksonville, Florida  32258
Florida Oncology AssociatesOrange Park, Florida  32073
Florida Cancer Center - PalatkaPalatka, Florida  32177
Flagler Cancer CenterSaint Augustine, Florida  32086
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
Galesburg Clinic, PCGalesburg, Illinois  61401
Boston University Cancer Research CenterBoston, Massachusetts  02118
Mercy General HospitalSacramento, California  95819
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Bay MedicalPanama City, Florida  32401
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint LouisSt Louis, Missouri  63110
Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey  08103
Precision Radiotherapy at University PointeWest Chester, Ohio  45069
Frankford Hospital Cancer Center - Torresdale CampusPhiladelphia, Pennsylvania  19114
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Harrison Medical CenterBremerton, Washington  98310
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. PetersSaint Peters, Missouri  63376
Norris Cotton Cancer Center - NorthSaint Johnsbury, Vermont  05819
Integrated Community Oncology Network at Southside Cancer CenterJacksonville, Florida  32207
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
New Mexico Cancer CenterAlbuquerque, New Mexico  87109
Central Indiana Cancer Centers - EastIndianapolis, Indiana  46219
Willamette Valley Cancer Center - EugeneEugene, Oregon  97401
Klabzuba Cancer Center at Harris Methodist Fort Worth HospitalFort Worth, Texas  76104
Texas Oncology, PA at Texas Cancer Center - ShermanSherman, Texas  75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar LandSugar Land, Texas  77479
Arizona Oncology - TucsonTucson, Arizona  85704
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
Texas Oncology, PA at Texas Cancer Center Dallas SouthwestDallas, Texas  75237
St. Vincent Oncology CenterIndianapolis, Indiana  46260