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

NCT00068744 | Terminated Phase 2

• 3 other identifiers: EORTC-22011-40014EORTC-22011EORTC-40014
• Study Type: interventional
• Target: 88
• Locations: 7 countries
• Sites: 24

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.

Conditions

Anal Cancer

Keywords

squamous cell carcinoma of the anus; stage II anal cancer; stage IIIA anal cancer; stage IIIB anal cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Interventions

cisplatin DRUG

fluorouracil DRUG

mitomycin C DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (24)

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, B-2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Centre Hospitalier Lyon Sud

Brussels, 1200, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Urologische Klinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

Berlin, D-13122, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Universitaetsklinikum Halle

Halle, D-06097, Germany

Location

Onkologische Schwerpunktpraxis - Leer

Leer, D-26789, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Ospedale Sant Anna

Como, 22100, Italy

Location

Ospedale Busonera - Divisione Oncologia Medica

Padua, 35128, Italy

Location

Arnhems Radiotherapeutisch Instituut

Arnhem, 6815 AD, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Institute of Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Related Publications (1)

• 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.

  PMID: 19643599 RESULT

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Cisplatin; Fluorouracil; Mitomycin; Radiotherapy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Jean-Francois Bosset, MD

  Hopital Jean Minjoz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: July 1, 2003
• Primary Completion: November 1, 2007
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

DE (7); EG (1); SE (1); BE (8); FR (3); IT (2); NL (2)