Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This research is being done with the aim of developing a more effective treatment than standard radiotherapy and surgery alone. Although standard treatment is frequently successful, some patients do not respond well to this treatment. Low oxygen levels in tumours, which may be a particular problem with sarcomas, are thought to be one factor that contributes to failure of radiotherapy. Sunitinib is a new drug that is active against cells with low oxygen levels. The combination of sunitinib and radiotherapy has shown promising results in other cancers. The purpose of this study is to find out whether treatment with a new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells; to test the safety of the combination of sunitinib and radiotherapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Australasian Sarcoma Study Group
• Collaborators: Peter MacCallum Cancer Centre, Australia; Pfizer
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• Histologically confirmed soft-tissue sarcoma suitable for neoadjuvant radiotherapy and surgery

• minimum age 16 years

• ECOG performance status =1

• life expectancy of greater than 6 months

• patients must have normal organ and marrow function

• no evidence of a bleeding or thrombotic tendency, and no evidence of arterial or venous thrombosis

• not pregnant or breastfeeding

• the ability to give written informed consent.

Exclusion Criteria:

• Soft-tissue sarcoma located in sites where radiotherapy is associated with significant exposure of abdominal viscera

• patients with other invasive malignancies, with the exception of non-melanoma skin cancer, in the last 5 years

• patients receiving any other therapeutic investigational agents

• patients who are receiving concurrent treatment with any other anti-cancer therapy

• evidence of distant metastases

• uncontrolled intercurrent illness

• patients who are pregnant or breast feeding.