• Objective tumor response rate [ Designated as safety issue: No ]
  

• Tolerability [ Designated as safety issue: Yes ]
  
• Rate of preservation of functional integrity of the anal sphincter [ Designated as safety issue: No ]
  
• Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation [ Designated as safety issue: No ]
  

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.

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