Clinical Trial: Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Ph

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer .

PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer.


Detailed Summary:

OBJECTIVES:

Phase II

  • Primary

    • Compare the early clinical response (tumor response at 8 weeks) of patients with locally advanced anal cancer treated with radiotherapy with mitomycin and cisplatin vs mitomycin and fluorouracil.

  • Secondary

    • Compare the feasibility of these regimens in these patients.
    • Compare the acute toxicity of these regimens in these patients.
    • Compare patient compliance to these regimens.

Phase III

  • Primary

    • Compare the event-free survival of patients treated with these regimens.

  • Secondary

    • Compare colostomy-free, disease-free, and overall survival of patients treated with these regimens.
    • Compare locoregional control in patients treated with these regimens.
    • Compare the late toxicity of these regimens in these patients.
    • Compare quality of life of patients treated with these regimens.

OUTLINE: Thi
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome:

  • Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II)
  • Event-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)


Original Primary Outcome:

Current Secondary Outcome:

  • Acute toxicity and compliance to treatment as measured by CTC v 2.0 at completion of study treatment (Phase II)
  • Colostomy-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
  • Overall survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
  • Disease-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
  • Local control as measured by Gray at 12 and 26 weeks, then every 6 months thereafter
  • Late toxicity as measured by RTOG and EROTC every 6 months after week 26
  • Quality of life as measured by EORTC Quality of Life Questionnaire-C30 and ASCT at 12 and 26 weeks, then every 6 months for 2 years after entry


Original Secondary Outcome:

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: September 10, 2003
Date Started: July 2003
Date Completion:
Last Updated: September 20, 2012
Last Verified: September 2012