Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2016

Conditions
Soft Tissue Sarcoma
Interventions
DRUG

Sunitinib malate

Sunitinib dose 50 mg/day orally for 2 weeks prior to radiotherapy. Treatment Dose Levels during radiotherapy: Dose level 0: Sunitinib 50mg/day for 2 weeks prior to radiotherapy, followed by 25mg/day given concurrently with radiotherapy; Dose level 1: Sunitinib 50mg/day for 2 weeks prior to radiotherapy, followed by 37.5mg/day given concurrently with radiotherapy; Dose level -1: Sunitinib 37.5mg/day for 2 weeks prior to radiotherapy, followed by 37.5mg/day given concurrently with radiotherapy. Dose escalation/de-escalation: first 6 patients will be accrued at dose level 0. The dose levels at which subsequent patients will be accrued will be determined using a dose modification schedule.

RADIATION

Radiotherapy

Preoperative radiotherapy consisting of external beam radiotherapy at a dose of 50.4 Gy given in 28 fractions, five days a week, over five weeks and 3 days to the planning target volume.

Trial Locations (1)

3002

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Peter MacCallum Cancer Centre, Australia

OTHER

collaborator

Pfizer

INDUSTRY

lead

Australasian Sarcoma Study Group

OTHER