Clinical trial · Interventional
Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
A Phase IB/II Study of Sunitinib in Combination With Neoadjuvant Radiation in Patients With Resectable Soft-tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the maximum dose of sunitinib at which the combination of sunitinib and radiotherapy pre-operatively is safe and tolerable.
- timeFrame
- Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; 12 weeks post-surgery
Secondary outcomes (1)
- measure
- To estimate response rates for the combination of sunitinib and radiotherapy.
- timeFrame
- Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; and at surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available