Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer
NCT ID: NCT00068744
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
88 participants
INTERVENTIONAL
2003-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
fluorouracil
mitomycin C
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Jean-Francois Bosset, MD
Role: STUDY_CHAIR
Hopital Jean Minjoz
Locations
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Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Centre Hospitalier Lyon Sud
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, , Belgium
National Cancer Institute of Egypt
Cairo, , Egypt
Institut Sainte Catherine
Avignon, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Urologische Klinik - Universitaetsklinikum Aachen
Aachen, , Germany
Charite - Campus Charite Mitte
Berlin, , Germany
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Halle
Halle, , Germany
Onkologische Schwerpunktpraxis - Leer
Leer, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Ospedale Sant Anna
Como, , Italy
Ospedale Busonera - Divisione Oncologia Medica
Padua, , Italy
Arnhems Radiotherapeutisch Instituut
Arnhem, , Netherlands
Dr. Bernard Verbeeten Instituut
Tilburg, , Netherlands
Institute of Oncology and Radiology of Serbia
Belgrade, , Serbia
Countries
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References
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Matzinger O, Roelofsen F, Mineur L, Koswig S, Van Der Steen-Banasik EM, Van Houtte P, Haustermans K, Radosevic-Jelic L, Mueller RP, Maingon P, Collette L, Bosset JF; EORTC Radiation Oncology and Gastrointestinal Tract Cancer Groups. Mitomycin C with continuous fluorouracil or with cisplatin in combination with radiotherapy for locally advanced anal cancer (European Organisation for Research and Treatment of Cancer phase II study 22011-40014). Eur J Cancer. 2009 Nov;45(16):2782-91. doi: 10.1016/j.ejca.2009.06.020. Epub 2009 Jul 28.
Other Identifiers
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EORTC-22011
Identifier Type: -
Identifier Source: secondary_id
EORTC-40014
Identifier Type: -
Identifier Source: secondary_id
EORTC-22011-40014
Identifier Type: -
Identifier Source: org_study_id