Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

June 25, 2021

Study Completion Date

December 31, 2025

Conditions
Locally Advanced Anal Canal Cancer
Interventions
DRUG

5Fluorouracile and Mitomycin-C

All the patients will receive radiochemotherapy with two cycles of 5FU (1,000 mg/m²/d with 96-h infusion, days 1-5 and 29-33 of SIB-IMRT) and Mitomycin-C (10 mg/m², days 1 and 29).

RADIATION

Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy

SIB-IMRT schedule of 61.2 Gy/1.7 Gy to the primary tumor, 57.60 Gy / 1.6 Gy to involved nodes, and 54 / 1.5 Gy to elective pelvic lymph nodes.

Trial Locations (8)

14076

Centre François Baclesse, Caen

44805

Institut de cancérologie de l'Ouest, Saint-Herblain

54519

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

Unknown

Institut de Cancérologie de l'Ouest - Centre Paul Papin, Angers

Centre Léon Berard, Lyon

Centre Antoine Lacassagne, Nice

Centre Paul Strauss, Strasbourg

IUCT-Oncopole, Toulouse

All Listed Sponsors
collaborator

Accuray Incorporated

INDUSTRY

lead

Centre Francois Baclesse

OTHER