Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Oncology | Gastroenterology
Disease Category: Colorectal Cancer

Trial Information

Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer RTOG 0822

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.

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
• Stage IIIB-IIIC disease (T3-T4, N0-2, M0)(i.e., without evidence of distant metastases) tumor as determined by the following assessments:
  • Colonoscopy and biopsy within the past 8 weeks
  • History/physical examination (including medication history screen for contraindications) within the past 8 weeks
  • Contrast-enhanced imaging of the abdomen and pelvis either by CT, MRI, or PET-CT (whole body preferred) within the past 8 weeks
  • Chest x-ray (or CT) of the chest within the past 8 weeks to exclude distant metastases (except for patients who have had whole body PET-CT)
  • Transrectal ultrasound (TRUS) within the past 8 weeks 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 = 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 < 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 CONCURRENT THERAPY:

• No prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided it was for a cancer other than colorectal cancer)
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
• More than 28 days since prior major surgery (other than diverting colostomy without tumor resection)
• More than 28 days since prior participation in any other investigational drug study
• No concurrent cimetidine, amifostine, and/or depot Sandostatin

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

View Google Map

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.