Radiation Therapy With or Without Chemotherapy Before Surgery in Treating Patients With Stage II or Stage III Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

762 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-04-30

Study Completion Date

2008-08-31

Brief Summary

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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without chemotherapy when given before surgery for rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy given together with fluorouracil and leucovorin to see how well they work compared to giving radiation therapy alone before surgery in treating patients with stage II or stage III rectal cancer.

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Detailed Description

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OBJECTIVES:

* Compare the recurrence-free and overall survival of patients with resectable stage II or III adenocarcinoma of the rectum treated with neoadjuvant radiotherapy with or without concurrent chemotherapy comprising fluorouracil and leucovorin calcium followed by surgery and adjuvant fluorouracil and leucovorin calcium.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, gender, location of the tumor relative to the anal margin (0-5 cm vs \> 5 cm), and tumor stage (T3 vs T4). Patients are randomized to 1 of 2 treatment arms.

* Neoadjuvant therapy: Patients are randomized to 1 of 2 neoadjuvant therapy arms.

* Arm I: Patients receive leucovorin calcium IV and fluorouracil IV over 15 minutes on days 1-5. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent radiotherapy 5 days a week for 5 weeks.
* Arm II: Patients undergo radiotherapy as in arm I.
* Surgery: In both arms, patients undergo surgical resection within 3-10 weeks after completing neoadjuvant therapy.
* Adjuvant therapy: Within 3-10 weeks after surgery, all patients receive adjuvant chemotherapy comprising leucovorin calcium IV and fluorouracil IV over 15 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for at least 5 years.

PROJECTED ACCRUAL: A total of 762 patients will be accrued for this study.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy

RT was delivered with photons from a linear accelerator with an energy level of 8MVor above.

Group Type ACTIVE_COMPARATOR

conventional surgery

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Chemotherapy and radiotherapy

The first CT cycle was administered from days 1 to 5 of the RT treatment. LV 20 mg/m2/d was delivered intravenously immediately before administration of FU. FU 350 mg/m2/d was delivered during 20 minutes in 100 mL of saline infusion, 1 hour before RT. The second cycle was administered from days 29 to 33 of the RT treatment using the same schedule.

Group Type EXPERIMENTAL

fluorouracil

Intervention Type DRUG

leucovorin calcium

Intervention Type DRUG

conventional surgery

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Interventions

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fluorouracil

Intervention Type DRUG

leucovorin calcium

Intervention Type DRUG

conventional surgery

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following stage criteria:

* Stage T3, N0-2, M0 disease meeting 1 of the following criteria:

* Invasive disease in entire circumference (circular tumor)
* Tumor fixed laterally or posteriorly to pelvic structures
* Tumor adherent to the prostate and/or seminal vesicles
* Tumor infiltration into the vaginal-rectal septum
* Tumor classified as uT3 by rectal endoscopy
* Stage T4, N0-2, M0 disease meeting 1 of the following criteria:

* Clinical or radiologic evidence of pelvic organ extension (vagina, prostate, seminal vesicles, or bladder)
* Tumor extension to the anal canal or sphincter
* Tumor classified as uT4 by rectal endoscopy
* Tumor accessible by digital rectal exam
* Resectable disease
* No distant metastases

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* Creatinine \< 1.36 mg/dL
* Granulocyte count \> 2,000/mm\^3
* Platelet count \> 130,000/mm\^3
* No progressive ischemic cardiomyopathy
* No acute or chronic obstruction unless treated with diversion colostomy
* No chronic inflammation of the ileum and/or colon
* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy, radiotherapy, or surgery for this cancer

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No