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A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer


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

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Trial Information

A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer


OBJECTIVES:

Primary

- To determine whether the incidence of neoadjuvant acute gastrointestinal toxicity
(grade ≥ 2) associated with neoadjuvant chemoradiotherapy is reduced by inverse-planned
intensity-modulated radiotherapy (IMRT)-based radiation treatment when compared with
conventionally delivered radiotherapy, as was utilized in the capecitabine and
oxaliplatin arm of RTOG-0247 (NCT00081289).

Secondary

- To evaluate the feasibility of performing IMRT in a cooperative group setting for the
treatment of rectal cancer.

- To estimate the incidence of all toxicity (hematologic and non-hematologic) associated
with protocol treatment in the neoadjuvant period, the adjuvant period, and overall.

- To estimate the pathologic complete response rate following neoadjuvant IMRT-based
chemoradiotherapy.

- To estimate the time to treatment failure and patterns of failure.

- To correlate pre- and post-treatment levels of serum cytokines with symptoms during and
pathological outcomes following neoadjuvant chemoradiotherapy for rectal cancer.

- To evaluate the rate of abdominoperineal resections.

OUTLINE: This is a multicenter study.

- Chemoradiotherapy: Patients undergo inverse-planned intensity-modulated radiotherapy to
the pelvis once daily, 5 days a week, for 5 weeks (total of 45 Gy) and a 3-dimensional
conformal radiotherapy boost to gross disease once daily for 3 days (total of 45 Gy).
Beginning on the first day of radiotherapy and continuing through completion of
radiotherapy, patients receive oral capecitabine twice daily, 5 days a week, for 5
weeks and oxaliplatin IV over 2 hours on days 1, 8, 15, 22, 29.

- Surgery: Within 4-8 weeks after completion of chemoradiotherapy, patients undergo
resection of the rectal tumor.

- Adjuvant chemotherapy: Beginning 4-8 weeks after surgery, patients with completely
resected disease and negative surgical margins receive leucovorin calcium IV over 2
hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV bolus on day 1 and
fluorouracil IV infusion continuously over 46 hours beginning on day 1 . Treatment
repeats every 14 days for up to 9 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months after the start of treatment for 2 years, every 6
months for years 3-5, and then annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy
technique that does not completely excise the lesion (e.g., fine needle aspiration,
core needle biopsy)

- Located up to 12 cm from the anal verge with no extension of malignant disease
into the anal canal

- Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by
the following assessments:

- Colonoscopy and biopsy within 56 days prior to registration

- History/physical examination (including medication history screen for
contraindications) within 56 days prior to registration

- Contrast-enhanced imaging of the abdomen and pelvis either by CT, MRI, or
PET-CT (whole body preferred) within 56 days prior to registration

- Chest x-ray (or CT) of the chest within within 56 days prior to
registration to exclude distant metastases (except for patients who have
had whole body PET-CT)

- Transrectal ultrasound (TRUS) within 56 days prior to registration required
to establish tumor stage

- TRUS not required if clinical exam, CT of the pelvis, and/or MRI
demonstrates T4 lesion

- No synchronous primary colon carcinoma

- No evidence of distant metastases (M1)

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Zubrod performance status 0-2

- ANC (absolute neutrophil count) ≥ 1,800/mm³

- Platelet count ≥ 100,000/mm³

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

- AST (aspartate aminotransferase) < 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase < 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- Creatinine clearance > 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a
minimum of 3 years

Exclusion criteria:

- Severe, active comorbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 12 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within the past 30 days

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

- AIDS

- Evidence of uncontrolled seizures, central nervous system disorders, or
psychiatric disability judged by the investigator to be clinically significant,
precluding informed consent, or interfering with compliance of oral drug intake

- Known, existing uncontrolled coagulopathy, unless clinically stable on
anticoagulation therapy for ≥ 2 weeks

- Evidence of peripheral neuropathy ≥ grade 2

- Prior allergic reaction to oxaliplatin or capecitabine

- Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease
that results in malabsorption; significant bowel resection that would make one
concerned about the absorption of capecitabine) or malabsorption syndrome that would
preclude feasibility of oral chemotherapy (i.e., capecitabine)

- Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed
provided it was for a cancer other than colorectal cancer)

- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiotherapy fields

- Major surgery within 28 days of study enrollment(other than diverting colostomy
without tumor resection)

- Participation in any investigational drug study within 28 days of study enrollment.

- Concurrent cimetidine, amifostine, and/or depot Sandostatin

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively

Outcome Description:

The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.

Outcome Time Frame:

From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)

Safety Issue:

Yes

Principal Investigator

Michael C. Garofalo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

RTOG-0822

NCT ID:

NCT00613080

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III rectal cancer
  • adenocarcinoma of the rectum
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

CCOP - Kansas CityKansas City, Missouri  64131
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
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
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
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
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
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
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Maimonides Cancer Center at Maimonides Medical CenterBrooklyn, New York  11219
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Piedmont HospitalAtlanta, Georgia  30309
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
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
Massachusetts General HospitalBoston, Massachusetts  02114-2617
California Cancer Center - Woodward Park OfficeFresno, California  93720
Cancer Center at Ball Memorial HospitalMuncie, Indiana  47303
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Cancer Treatment CenterWooster, Ohio  44691
John B. Amos Cancer CenterColumbus, Georgia  31904
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Truman Medical Center - Hospital HillKansas City, Missouri  64108
St. Joseph Medical CenterKansas City, Missouri  64114
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
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
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Solano Radiation Oncology CenterVacaville, California  95687
Boston University Cancer Research CenterBoston, Massachusetts  02118
Parvin Radiation OncologyKansas City, Missouri  64116
Mercy General HospitalSacramento, California  95819
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Riddle Memorial Hospital Cancer CenterMedia, Pennsylvania  19063
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
Dale and Frances Hughes Cancer Center at Pocono Medical CenterEast Stroudsburg, Pennsylvania  18301
Cancer Care Center, IncorporatedSalem, Ohio  44460
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
Bay MedicalPanama City, Florida  32401
Cancer Institute of Cape Girardeau, LLCCape Girardeau, Missouri  63703
J. Phillip Citta Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
Precision Radiotherapy at University PointeWest Chester, Ohio  45069
Integrated Community Oncology Network - Orange ParkOrange Park, Florida  32073
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care CenterMilwaukee, Wisconsin  53211
Frankford Hospital Cancer Center - Torresdale CampusPhiladelphia, Pennsylvania  19114
Integris Oncology ServicesOklahoma City, Oklahoma  73112
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main CampusBoca Raton, Florida  33486
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Saint John's Cancer Center at Saint John's Medical CenterAnderson, Indiana  46016
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Barnes-Jewish West County HospitalSaint Louis, Missouri  63141
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. PetersSaint Peters, Missouri  63376
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Norris Cotton Cancer Center - NorthSaint Johnsbury, Vermont  05819
Northeast Radiation Oncology CenterDunmore, Pennsylvania  18512
Nebraska Medical CenterOmaha, Nebraska  68198
Upper Delaware Valley Cancer CenterMilford, Pennsylvania  18337
St. Vincent Oncology CenterIndianapolis, Indiana  46260