Preoperative Radiotherapy With or Without Concurrent Chemotherapy (5-Fluorouracil and Leucovorin) in T3-4 Rectal Cancers - Randomized Trial


Phase 3
N/A
75 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Preoperative Radiotherapy With or Without Concurrent Chemotherapy (5-Fluorouracil and Leucovorin) in T3-4 Rectal Cancers - Randomized Trial


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jean-Pierre Gerard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

United States: Federal Government

Study ID:

CDR0000466625

NCT ID:

NCT00296608

Start Date:

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • adenocarcinoma of the rectum
  • Rectal Neoplasms
  • Colorectal Neoplasms

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