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

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ClinicalTrials.gov Identifier: NCT00006366
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: fluorouracil Drug: irinotecan hydrochloride Procedure: conventional surgery Radiation: radiation therapy Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer
Study Start Date : February 2001
Actual Primary Completion Date : December 2003




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006366


  Show 235 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Mohammed M. Mohiuddin, MD Lucille P. Markey Cancer Center at University of Kentucky

Publications of Results:
Mohiuddin M, Garcia M, Mitchell E, et al.: 3-year results of RTOG-0012 randomized phase II study of neoadjuvant combined modality chemoradiation for distal rectal cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2092, S260, 2006.
Mitchell EP, Winter K, Mohiuddin M, et al.: Randomized phase II trial of preoperative combined modality chemoradiation for distal rectal cancer. [Abstract] J Clin Oncol 22 (Suppl 14): A-3535, 253s, 2004.
Mohiuddin M, Winter K, Mitchell E, et al.: Results of RTOG-0012 randomized phase II study of neoadjuvant combined modality chemoradiation for distal rectal cancer. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-16, S138, 2004.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00006366     History of Changes
Other Study ID Numbers: RTOG-R-0012
CDR0000068239
RTOG-DEV-1030
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: December 2002

Keywords provided by Radiation Therapy Oncology Group:
stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs