NCT00023751
Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer
PHASE2
COMPLETED
NCT00023751
INTERVENTIONAL
A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer.
PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the rectum
* T1 or T2 by physical and endoscopic exams
* No T3 lesions by clinical or radiological exam
* Villous adenomas or in situ carcinoma allowed without histologicalconfirmation if clinical appearance of cancer
* No multi-focal disease within the rectum at time of initial diagnosis
* No non-adenocarcinomatous rectal cancer or anal cancer
* Less than 4 cm at greatest diameter
* Less than 40% of rectal wall circumference involved
* Proximal margin no greater than 8 cm from dentate line
* No tumor fixation to the perirectal tissues regardless of size
* No malignant regional lymph node or distant metastases by clinical exam orradiographical imaging
* No palpable perirectal lymph nodes or nodes larger than 1 cm
* No evidence of malignant perirectal lymph nodes by endorectal ultrasound orendorectal MRI
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* CTC 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times normal
Renal:
* Creatinine less than 1.8 mg/dL
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* No prior surgery for rectal cancer including prior attempts at transanal or transcoccygeal surgical excision with unclear or positive margins
* Prior incision or operative biopsy or colonoscopic removal allowed
Colorectal Cancer
- TREATMENT
-
- Type: DRUG
- Name: fluorouracil
- Description:
- Arm Group Labels: surgery + leucovorin + fluorouracil + radiation
-
- Type: DRUG
- Name: leucovorin calcium
- Description:
- Arm Group Labels: surgery + leucovorin + fluorouracil + radiation
-
- Type: PROCEDURE
- Name: conventional surgery
- Description:
- Arm Group Labels: surgery + leucovorin + fluorouracil + radiation
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: surgery + leucovorin + fluorouracil + radiation
- Alliance for Clinical Trials in Oncology