Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase

Unknown

Phase 2

Conditions

Colorectal Cancer

Treatments

Radiation: radiation therapy

Procedure: conventional surgery

Procedure: neoadjuvant therapy

Drug: capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00075556

EU-20329

CDR0000346895

FRE-GERCOR-R01-01

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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