Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer

This study has been completed.
Southwest Oncology Group
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 13, 2001
Last updated: February 6, 2009
Last verified: October 2003

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer.

PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.

Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2001
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the overall, disease-free, and colostomy-free survival rates in patients with stage I rectal cancer treated with local excision with or without adjuvant chemotherapy and radiotherapy.
  • Determine the local, regional, and distant recurrence rates in patients treated with these regimens.
  • Determine whether loco-regional recurrences after local excision can be successfully salvaged with radical surgery with or without adjuvant therapy for permanent cure in patients treated with these regimens.
  • Determine whether the analysis of certain histological and molecular markers can help determine prognosis in patients treated with these regimens.
  • Determine the anorectal, urinary, and sexual function effects in patients treated with these regimens.
  • Determine the non-functional treatment morbidity and mortality exclusive of anorectal, urinary, and sexual function effects in patients treated with these regimens.
  • Determine the overall survival of patients with pathology exclusions undergoing local excision.
  • Determine the efficacy of the current standard in detecting recurrence during follow-up, including office visits, blood tests, and proctoscopy in patients treated with these regimens.

OUTLINE: This is a multicenter study.

All patients undergo full thickness disc excision. Patients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy.

Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses.

Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

PROJECTED ACCRUAL: Approximately 320 patients will be accrued for this study within 5 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the rectum

    • T1 or T2 by physical and endoscopic exams
    • No T3 lesions by clinical or radiological exam
    • Villous adenomas or in situ carcinoma allowed without histologicalconfirmation if clinical appearance of cancer
  • No multi-focal disease within the rectum at time of initial diagnosis
  • No non-adenocarcinomatous rectal cancer or anal cancer
  • Less than 4 cm at greatest diameter
  • Less than 40% of rectal wall circumference involved
  • Proximal margin no greater than 8 cm from dentate line
  • No tumor fixation to the perirectal tissues regardless of size
  • No malignant regional lymph node or distant metastases by clinical exam orradiographical imaging

    • No palpable perirectal lymph nodes or nodes larger than 1 cm
    • No evidence of malignant perirectal lymph nodes by endorectal ultrasound orendorectal MRI



  • 18 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 1.5 times normal


  • Creatinine less than 1.8 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • No prior surgery for rectal cancer including prior attempts at transanal or transcoccygeal surgical excision with unclear or positive margins
  • Prior incision or operative biopsy or colonoscopic removal allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00023751

  Show 180 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Southwest Oncology Group
Study Chair: Ronald Bleday, MD Dana-Farber/Brigham and Women's Cancer Center
Study Chair: Morton S. Kahlenberg, MD The University of Texas Health Science Center at San Antonio
  More Information

Additional Information:
No publications provided Identifier: NCT00023751     History of Changes
Other Study ID Numbers: CDR0000068858, CLB-80002, SWOG-C80002
Study First Received: September 13, 2001
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I rectal cancer
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents processed this record on July 01, 2015