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Lead
GERCOR - Multidisciplinary Oncology Cooperative Group
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
