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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00006366
First received: October 4, 2000
Last updated: July 17, 2013
Last verified: December 2002

October 4, 2000
July 17, 2013
February 2001
December 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006366 on ClinicalTrials.gov Archive Site
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Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer

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.

OBJECTIVES:

  • Compare the pathological complete response, acute and late normal tissue morbidity, patterns of failure, and complete resection rates in patients with locally advanced adenocarcinoma of the distal rectum treated with neoadjuvant chemoradiotherapy comprised of hyperfractionated radiotherapy and fluorouracil vs conventional radiotherapy, fluorouracil, and irinotecan, followed by radical resection.

OUTLINE: This is a randomized study. Patients are stratified according to clinical stage (T3 vs T4). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive hyperfractionated radiotherapy (RT) twice daily, 5 days a week for 19 days. Patients receive fluorouracil IV continuously over 7 days a week concurrently with RT. Patients with clinical stage T3 or fixed T4 disease also receive a higher boost dose of RT to tumor.
  • Arm II: Patients receive conventional RT once daily, 5 days a week for 25 days. Patients receive fluorouracil IV continuously over 5 days a week concurrently with RT. Patients receive irinotecan IV over 1 hour (immediately prior to RT dose) once weekly for 4 weeks. Patients with clinical stage T3 or fixed T4 disease also receive a lower boost dose of RT to tumor.

Within 4-10 weeks after completion of chemoradiotherapy, patients on both arms undergo radical anterior resection or radical abdominal perineal resection with preferably a total mesorectal resection.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 18 months.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00006366
RTOG-R-0012, CDR0000068239, RTOG-DEV-1030
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Mohammed M. Mohiuddin, MD Lucille P. Markey Cancer Center at University of Kentucky
Radiation Therapy Oncology Group
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP