Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.

Key facts

Study ID

NCT00613080

Run by

Radiation Therapy Oncology Group

People needed

79

Starts

2008-04-01

Expected to finish

2016-12-01

Last updated by the study team

2018-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Zubrod performance status 0-2
• Absolute neutrophil count (ANC) ≥ 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)
• Aspartate aminotransferase (AST) < 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

You may not qualify if…

• 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

Where it is running

• Auburn Radiation Oncology — Auburn, California, United States
• Radiation Oncology Centers - Cameron Park — Cameron Park, California, United States
• Mercy Cancer Center at Mercy San Juan Medical Center — Carmichael, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• California Cancer Center - Woodward Park Office — Fresno, California, United States
• Rebecca and John Moores UCSD Cancer Center — La Jolla, California, United States
• Radiation Oncology Center - Roseville — Roseville, California, United States
• Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento, California, United States
• Mercy General Hospital — Sacramento, California, United States
• Veterans Affairs Medical Center - San Diego — San Diego, California, United States
• Solano Radiation Oncology Center — Vacaville, California, United States
• Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus — Boca Raton, Florida, United States
• University of Florida Shands Cancer Center — Gainesville, Florida, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• Baptist-South Miami Regional Cancer Program — Miami, Florida, United States
• Integrated Community Oncology Network - Orange Park — Orange Park, Florida, United States
• Bay Medical — Panama City, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• John B. Amos Cancer Center — Columbus, Georgia, United States
• Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center — Savannah, Georgia, United States
• Cancer Institute at St. John's Hospital — Springfield, Illinois, United States
• Saint John's Cancer Center at Saint John's Medical Center — Anderson, Indiana, United States
• Center for Cancer Care at Goshen General Hospital — Goshen, Indiana, United States
• St. Vincent Oncology Center — Indianapolis, Indiana, United States
• Providence Cancer Center at Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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