Clinical trial · Interventional
Safety Study of Preoperative Sunitinib and Radiation in Soft Tissue Sarcoma
Phase 1 Trial of Concurrent Sunitinib and Radiation Therapy as Preoperative Treatment for Locally Advanced or Recurrent Soft Tissue Sarcoma.
NCT01498835CI-TRIAL-00029290SunRaSecompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate the toxicity of sunitinib concurrently given with irradiation for preoperative treatment of locally advanced or recurrent soft tissue sarcoma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined Sunitinib and irradiation
- description
- Patients with locally advanced or recurrent soft tissue sarcoma will receive Sunitinib and irradiation as neoadjuvant treatment. Restaging and tumor resection will be performed 6 weeks after completion of sunitinib and irradiation.
- interventionNames
- Drug: Sunitinib
Primary outcomes (1)
- measure
- To evaluate the dose limiting toxicity and maximal tolerated dose of sunitinib given concurrently with irradiation as neoadjuvant treatment in soft tissue sarcoma.
- timeFrame
- 12 weeks
- description
- Toxicity of the study treatment will be documented according to CTCAE 4.0 during and until 4 weeks after study treatment.
Secondary outcomes (1)
- measure
- To evaluate the response to sunitinib given concurrently with radiation as neoadjuvant treatment in soft tissue sarcoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven soft tissue sarcoma of any histology but GIST, Angiosarcoma, dermatofibrosarcoma protuberans, Ewing Sarcoma or Embryonal Rhabdomyosarcoma * patients with primary tumors OR with local recurrences who did not receive prior radiation therapy OR with solitary metastatic lesions may be included * complete resection after neoadjuvant treatment is expected * age of 18 or older * ECOG performance score 0 or 1 * normal organ and bone marrow function * ability to give written informed consent Exclusion Criteria: * medication with inhibitors or inducers of CYP3A4 * prior therapy with tyrosine kinase inhibitors or conventional chemotherapy within 4 weeks before study inclusion * history of myocardial infarction, stroke or thromboembolic events * clinical signs of heart failure (NYHA 3 or 4) * anticoagulation with Vitamin K antagonists * acquired or hereditary coagulopathy * uncontrolled hypertension * uncontrolled intercurrent illness * women who are pregnant or breastfeeding
References
Publications (2)
- DERIVEDJakob J, Simeonova A, Kasper B, Ronellenfitsch U, Rauch G, Wenz F, Hohenberger P. Combined sunitinib and radiation therapy for preoperative treatment of soft tissue sarcoma: results of a phase I trial of the German interdisciplinary sarcoma group (GISG-03). Radiat Oncol. 2016 Jun 3;11:77. doi: 10.1186/s13014-016-0654-2. PMID 27255678
- DERIVEDJakob J, Rauch G, Wenz F, Hohenberger P. Phase I trial of concurrent sunitinib and radiation therapy as preoperative treatment for soft tissue sarcoma. BMJ Open. 2013 Sep 18;3(9):e003626. doi: 10.1136/bmjopen-2013-003626. PMID 24048627