Phase II Pilot Study of 5-FU/MITO plus Radiotherapy in Patients with Previously Untreated Carcinoma of the Anal Canal

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overNCIRTOG-9208


I.  Assess the acute tolerance to fluorouracil/mitomycin plus irradiation with 
59.4 Gy (increased radiation dose compared to RTOG-8704) in patients with 
carcinoma of the anal canal.

II.  Determine whether tolerance differs greatly in high-risk patients who are 

Entry Criteria

Disease Characteristics:

Histologically proven, previously untreated carcinoma of the anal canal of the
following histologies:
  Squamous cell

Stage T1-4, any N, M0 disease required

No in situ carcinoma of the anal canal

Primary lesion measurable and at least 2 cm at entry

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

  No prior chemotherapy for anal cancer

Endocrine therapy:
  Not specified

  No prior radiotherapy for anal cancer

  No prior surgery (other than excisional biopsy) for anal cancer

Patient Characteristics:

  18 and over

Performance status:
  Karnofsky 60-100%

  WBC at least 3,500
  Platelets at least 100,000

  Bilirubin no greater than 1.3 mg/dl

  Creatinine no greater than 1.4 mg/dl

  No second malignancy within 5 years except skin neoplasms
  No AIDS (HIV-seropositive patients eligible)

Expected Enrollment

18 patients will be treated.


Radiotherapy plus 2-Drug Combination Chemotherapy.  Pelvic irradiation using 
supervoltage equipment with energies of at least 6 MeV (electron or photon 
beams may be used for boosts); plus Fluorouracil, 5-FU, NSC-19893; Mitomycin, 
MITO, NSC-26980.

Published Results

Konski A, Garcia M Jr, John M, et al.: Evaluation of planned treatment breaks during radiation therapy for anal cancer: update of RTOG 92-08. Int J Radiat Oncol Biol Phys 72 (1): 114-8, 2008.[PUBMED Abstract]

Konski AA, Winter K, et al.: Evaluation of planned treatment breaks during radiation therapy for anal cancer: update of Radiation Therapy Oncology Group (RTOG) 92-08. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-297, 2007.

John M, Pajak T, Flam M, et al.: Dose acceleration in chemoradiation (CRX) for anal cancer: preliminary results of RTOG 92-08. Int J Radiat Oncol Biol Phys 32(suppl 1): A33, 157, 1995.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Marshall Flam, MD, FACP, Protocol chair
Ph: 559-447-4930

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.