Status:
UNKNOWN
Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
Lead Sponsor:
Australasian Sarcoma Study Group
Collaborating Sponsors:
Peter MacCallum Cancer Centre, Australia
Pfizer
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
16+ years
Phase:
PHASE1
PHASE2
Brief 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 n...
Detailed Description
The presence of hypoxia has been documented in soft-tissue sarcomas, where it may contribute to radioresistance. Combinations of radiosensitisers such as ifosfamide and doxorubicin with radiotherapy h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00753727
Start Date
September 1 2008
End Date
March 1 2016
Last Update
June 23 2011
Active Locations (1)
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1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002