NCT00006366

Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00006366

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy plus chemotherapy is more effective for rectal cancer.

PURPOSE: Randomized phase II trial to compare two regimens of radiation therapy plus chemotherapy followed by surgery in treating patients who have locally advanced cancer of the rectum.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the distal rectum

* Located 0-9 cm from the dentate line (3-12 cm from the anal verge)

* No extension of malignant disease into the anal canal
* Lesions may be mobile stage T3 by endorectal ultrasound OR fixed, defined as clinical stage T4, by palpation
* No evidence of distant metastases

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC (white blood cell count) greater than 4,000/mm\^3
* Platelet count greater than 130,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal
* Alkaline phosphatase, SGOT (serum glutamic oxaloacetic transaminase), and LDH (lactate dehydrogenase) normal

Renal:

* Creatinine normal

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years except:

* Inactive nonmelanomatous skin cancer
* Carcinoma in situ of the cervix
* Synchronous colonic cancer if tumor is Tis or T1 and has been completely resected
* No other serious medical illnesses

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to pelvis

Surgery:

* Not specified

Other:

* No concurrent antiepileptic drugs

Disease(s) and\or Condition(s)

Colorectal Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: fluorouracil
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: irinotecan hydrochloride
- Description:
- Arm Group Labels:
- Type: PROCEDURE
- Name: conventional surgery
- Description:
- Arm Group Labels:
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels:

Sponsor

Radiation Therapy Oncology Group