A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

October 31, 2021

Study Completion Date

May 31, 2022

Conditions
Soft-tissue Sarcoma
Interventions
DRUG

Olaparib

Olaparib will be administered per os bidaily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression.

RADIATION

Concomitant Radiotherapy

Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8.

Trial Locations (4)

31052

Institut Claudius Regaud - IUCT, Toulouse

33076

Institut Bergonié, Bordeaux

34298

Institut du Cancer de Montpellier, Montpellier

69373

Centre Léon Bérard, Lyon

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute, France

OTHER_GOV

lead

Institut Bergonié

OTHER