- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00068744
Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer
Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Antwerpen, Belgium, B-2020
- Ziekenhuis Netwerk Antwerpen Middelheim
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Brussels, Belgium, 1200
- Centre Hospitalier Lyon Sud
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Kortrijk, Belgium, B-8500
- Cazk Groeninghe - Campus Maria's Voorzienigheid
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Wilrijk, Belgium, 2610
- Algemeen Ziekenhuis Sint-Augustinus
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Cairo, Egypt
- National Cancer Institute of Egypt
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Avignon, France, 84082
- Institut Sainte Catherine
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Besancon, France, 25030
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
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Dijon, France, 21079
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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Aachen, Germany, D-52074
- Urologische Klinik - Universitaetsklinikum Aachen
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Berlin, Germany, D-10117
- Charité - Campus Charité Mitte
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Berlin, Germany, D-13122
- Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
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Essen, Germany, D-45122
- Universitaetsklinikum Essen
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Halle, Germany, D-06097
- Universitaetsklinikum Halle
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Leer, Germany, D-26789
- Onkologische Schwerpunktpraxis - Leer
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Tuebingen, Germany, D-72076
- Universitaetsklinikum Tuebingen
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Como, Italy, 22100
- Ospedale Sant Anna
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Padova, Italy, 35128
- Ospedale Busonera - Divisione Oncologia Medica
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Arnhem, Netherlands, 6815 AD
- Arnhems Radiotherapeutisch Instituut
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Tilburg, Netherlands, 5042 SB
- Dr. Bernard Verbeeten Instituut
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Belgrade, Serbia, 11000
- Institute of Oncology and Radiology of Serbia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell anal carcinoma
- Keratinizing or non-keratinizing
The following stages are eligible:
- T2, N0, M0 with maximum tumor diameter at least 4 cm
- T3-T4, N0, M0
- Any T, N1-N3, M0
- Tumor located in the anal canal OR in the anal margin and infiltrating the anal canal
- No primary adenocarcinoma of the anus
- Measurable disease
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine less than 1.4 mg/dL
Cardiovascular
- No grade I angina pectoris with clinical symptoms within the past 3 months
- No grade II-IV angina pectoris within the past 3 months
- No stage II or greater distal arteritis
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No other concurrent radiotherapy
Surgery
- No prior colostomy
Other
- No prior treatment for anal cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II)
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Event-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
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Secondary Outcome Measures
Outcome Measure |
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Acute toxicity and compliance to treatment as measured by CTC v 2.0 at completion of study treatment (Phase II)
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Colostomy-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
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Overall survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
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Disease-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
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Local control as measured by Gray at 12 and 26 weeks, then every 6 months thereafter
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Late toxicity as measured by RTOG and EROTC every 6 months after week 26
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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
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Collaborators and Investigators
Investigators
- Study Chair: Jean-Francois Bosset, MD, Hopital Jean Minjoz
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Anus Diseases
- Anus Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Alkylating Agents
- Antibiotics, Antineoplastic
- Cisplatin
- Fluorouracil
- Mitomycins
- Mitomycin
Other Study ID Numbers
- EORTC-22011-40014
- EORTC-22011
- EORTC-40014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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