Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer
18 Years
80 Years
Both
Colorectal Cancer
Trial Information
Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective tumor response rate
Safety Issue:
No
Principal Investigator
Olivier Dupuis, MD
Investigator Affiliation:
Centre Jean Bernard
Authority:
United States: Federal Government
Study ID:
CDR0000346895
NCT ID:
NCT00075556
Start Date:
January 2002
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage III colon cancer
- stage IV colon cancer
- stage III rectal cancer
- stage IV rectal cancer
- adenocarcinoma of the rectum
- adenocarcinoma of the colon
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Colorectal Neoplasms
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