Colorectal Cancer
Conditions
Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, adenocarcinoma of the rectum, adenocarcinoma of the colon
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and capecitabine work in treating patients who are undergoing surgery for stage III or stage IV colorectal adenocarcinoma.
Detailed description
OBJECTIVES: Primary * Determine the objective tumor response rate in patients with stage III or IV colorectal adenocarcinoma treated with neoadjuvant radiotherapy and capecitabine. Secondary * Determine the tolerance profile of this regimen in these patients. * Determine the rate of preservation of functional integrity of the anal sphincter in patients treated with this regimen. * Compare the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily and undergo concurrent radiotherapy 5 days a week on weeks 1-5. Patients undergo surgery on week 6. Patients are followed every 4 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 10 months.
Interventions
DRUGcapecitabine
PROCEDUREconventional surgery
PROCEDUREneoadjuvant therapy
RADIATIONradiation therapy
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colorectal adenocarcinoma * Clinical stage T3, T4, N+ * Measurable disease * Awaiting surgery and likely to benefit from neoadjuvant radiotherapy PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN * No hepatic condition that would interfere with study medication Renal * Creatinine clearance at least 80 mL/min * No renal condition that would interfere with study medication Cardiovascular * No serious cardiac failure with the past year * No myocardial infarction within the past year * No cardiac insufficiency * No angina * No uncontrolled arrhythmia * No uncontrolled hypertension Gastrointestinal * No superior intestinal tract malfunction * No malabsorption syndrome Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent serious infection * No other serious illness * No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No metabolic condition that would interfere with study medication * No dementia or altered mental status * No psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for colorectal cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for colorectal cancer Surgery * Not specified Other * More than 30 days since prior participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumor response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability | — |
| Rate of preservation of functional integrity of the anal sphincter | — |
| Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation | — |
Countries
France
Outcome results
None listed