Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
NCT00753727
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma | |||
Official Title ICMJE | A Phase IB/II Study of Sunitinib in Combination With Neoadjuvant Radiation in Patients With Resectable Soft-tissue Sarcoma | |||
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 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. | |||
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 have demonstrated promise in sarcomas, but with significant toxicity. The rationale for this study is based on:
Because the combination of sunitinib and radiotherapy has not been studied before, we propose a phase Ib design with dose reductions in the event of excessive toxicity. Sunitinib treatment will precede the commencement of radiotherapy by 2 weeks because there is preclinical evidence that priming the tumor vasculature may increase synergy with radiotherapy, and because sunitinib may have single agent activity in sarcomas, including measurable effects on tumor vasculature. Because it is anticipated that the likelihood of complications attributable to the combination of sunitinib and radiotherapy will be small, the starting dose of sunitinib will be 50mg/day for the two week lead-in period and then 25mg for 5 weeks with concurrent radiotherapy. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Soft Tissue Sarcoma | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE | 26 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | March 2016 | |||
Estimated Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00753727 | |||
Other Study ID Numbers ICMJE | ASSG01 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Associate Professor David Thomas, Peter MacCallum Cancer Centre | |||
Study Sponsor ICMJE | Australasian Sarcoma Study Group | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Australasian Sarcoma Study Group | |||
Verification Date | December 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |