Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer
- Conditions
- Anal Cancer
- Registration Number
- NCT00068744
- 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 Description
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: This is a randomized, multicenter study. Patients are stratified according to participating center, T stage (T2 vs T3 vs T4), and nodal status (N0 vs N+). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy once daily 5 days a week on weeks 1-4, 7-8, and 3 days of week 9 (total of 33 fractions). Patients concurrently receive fluorouracil IV continuously on days 1-26 and 43-59 and mitomycin IV over 15 minutes on days 1 and 43.
* Arm II: Patients receive radiotherapy and mitomycin as in arm I and cisplatin IV over 1 hour on days 1, 8, 15, 22, 43, 50, and 57.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at weeks 12 and 26, and then every 6 months for 2 years.
Patients are followed every 2 weeks for 8 weeks, at week 26, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 678 patients (80 \[40 per treatment arm\] for phase II and 598 \[299 per treatment arm\] for phase III) will be accrued for this study within 2-5 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 88
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method Disease-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter 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 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
Trial Locations
- Locations (24)
Institute of Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerpen, Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
Arnhems Radiotherapeutisch Instituut
🇳🇱Arnhem, Netherlands
Dr. Bernard Verbeeten Instituut
🇳🇱Tilburg, Netherlands
Ospedale Sant Anna
🇮🇹Como, Italy
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Universitaetsklinikum Halle
🇩🇪Halle, Germany
Institut Jules Bordet
🇧🇪Brussels, Belgium
Centre Hospitalier Lyon Sud
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
🇩🇪Berlin, Germany
Algemeen Ziekenhuis Sint-Augustinus
🇧🇪Wilrijk, Belgium
Ospedale Busonera - Divisione Oncologia Medica
🇮🇹Padova, Italy
Universitaetsklinikum Essen
🇩🇪Essen, Germany
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Institut Sainte Catherine
🇫🇷Avignon, France
Urologische Klinik - Universitaetsklinikum Aachen
🇩🇪Aachen, Germany
Onkologische Schwerpunktpraxis - Leer
🇩🇪Leer, Germany