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Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003596
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 4, 2017
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
SWOG Cancer Research Network
North Central Cancer Treatment Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus radiation therapy for anal cancer.

PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus radiation therapy to see how well it works compared to fluorouracil and cisplatin plus radiation therapy in treating patients with stage II or stage III anal cancer.

Condition or disease Intervention/treatment Phase
Anal Cancer Drug: cisplatin Drug: fluorouracil Drug: mitomycin C Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the initial and total local and distant failure rates in patients with anal canal cancer treated with either fluorouracil (5-FU) plus mitomycin concurrently with radiotherapy or 5-FU plus cisplatin followed by 5-FU plus cisplatin concurrently with radiotherapy.
  • Identify any differences in local control and colostomy rates at 2 years in patients treated with these regimens.
  • Determine any difference in colostomy free, disease free, or overall survival in patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Evaluate the prognostic effects of tumor markers P53 overexpression, human papilloma virus status, and enzyme HAP1 in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to gender, nodal status (positive vs negative), and primary tumor size (greater than 2 cm to 5 cm vs greater than 5 cm). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29 and mitomycin IV on days 1 and 29 with concurrent radiotherapy.
  • Arm II: Patients receive induction chemotherapy comprising 5-FU IV continuously over 96 hours beginning on days 1, 29, 57, and 85 and cisplatin IV over 1 hour on days 1, 29, 57, and 85. Beginning on day 57, patients receive concurrent radiotherapy.

In both arms, radiotherapy is administered daily, 5 days a week, for 5-6.5 weeks. Patients with T3, T4, or N+ lesions or T2 lesions with residual disease receive additional radiotherapy to a reduced field.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study within 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 682 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin, and Radiotherapy in Carcinoma of the Anal Canal
Study Start Date : October 1998
Actual Primary Completion Date : October 2005
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed primary squamous, basaloid, or cloacogenic carcinoma of the anal canal, other than carcinoma in situ

    • T2-4, Any N, M0 (stage II or III)
  • No local or regional recurrence after local excision or abdominal peritoneal resection



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Absolute neutrophil count at least 1,800/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin less than 1.4 mg/dL


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 80 mL/min


  • No uncompensated heart disease
  • No uncontrolled high blood pressure


  • No AIDS
  • No active systemic infection
  • No uncontrolled diabetes
  • No other prior malignancy within the past 5 years except nonmelanoma skin cancer
  • No mental condition that would preclude study participation
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Prior epoetin alfa allowed in lieu of blood transfusions


  • At least 5 years since prior chemotherapy

Endocrine therapy:

  • Not specified


  • At least 5 years since prior radiotherapy


  • No prior surgery of anal canal except for biopsy of study site

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): NCT00003596

Show Show 485 study locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
SWOG Cancer Research Network
North Central Cancer Treatment Group
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Study Chair: Jaffer A. Ajani, MD M.D. Anderson Cancer Center
Study Chair: Al B. Benson, MD, FACP Robert H. Lurie Cancer Center
Study Chair: Joel E. Tepper, MD UNC Lineberger Comprehensive Cancer Center
Study Chair: John S. MacDonald, MD Beth Israel Comprehensive Cancer Center - West Side Campus
Study Chair: Michael G. Haddock, MD Mayo Clinic
Publications of Results:
Gunderson LL, Winter KA, Ajani JA, et al.: Long-term update of U.S. GI intergroup RTOG 98-11 phase III trial for anal carcinoma: disease-free and overall survival with RT+5FU-mitomycin versus RT+5FU-cisplatin. [Abstract] J Clin Oncol 29 (Suppl 15): A-4005, 2011.
Gunderson LL, Moughan J, Ajani JA, et al.: Anal carcinoma: Impact of TN category of disease on survival, disease relapse, and colostomy failure in U.S. GI Intergroup RTOG 98-11 phase III trial. [Abstract] American Society of Clinical Oncology 2010 Gastrointestinal Cancers Symposium, 22-24 January 2010, Orlando, Florida. A-285, 2010.
Ajani JA, Winter KA, Gunderson LL, et al.: Intergroup RTOG 98-11: a phase III randomized study of 5-fluorouracil (5-FU), mitomycin, and radiotherapy versus 5-fluorouracil, cisplatin and radiotherapy in carcinoma of the anal canal. [Abstract] J Clin Oncol 24 (Suppl 18): A-4009, 2006.
Gunderson LL, Winter KA, Ajani JA, et al.: Intergroup RTOG 9811 phase III comparison of chemoradiation with 5-FU and mitomycin vs 5-FU and cisplatin for anal canal carcinoma: impact on disease-free, overall and colostomy-free survival. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-43, S24, 2006.

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003596    
Other Study ID Numbers: RTOG-9811
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016
Keywords provided by Radiation Therapy Oncology Group:
stage II anal cancer
stage III anal cancer
squamous cell carcinoma of the anus
cloacogenic carcinoma of the anus
basaloid carcinoma of the anus
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors