Clinical trial · Interventional
Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
- 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)
The purpose of this study is to determine the safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery. The primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery. This study is a multicentre, open-label phase I with dose escalation : 2 dose levels. 3-6 patients will be included at each dose level.3-18 patients will be included in the study.
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 |
|---|---|---|---|
| Non GIST Sarcomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- association sunitinib radiotherapy
- interventionNames
- Drug: sunitinib
Primary outcomes (1)
- measure
- the number of DLT occurring at each dose level of sunitinib within 14 weeks after the start of treatment
- timeFrame
- within 14 weeks after the start of treatment
Secondary outcomes (6)
- measure
- the number of early toxicities (within 14 weeks after the beginning of treatment) and late toxicities (after 14 weeks and until 12 months after the start of treatment) using NCI-CTC v3.0 and RTOG-EORTC
- timeFrame
- within 12 months after the start of treatment
- measure
- response rate at 6 months using MRI (magnetic resonance imaging)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients \> 18 years of age 2. Histologically or cytologically (in case of recurrence) confirmed connective tissue neoplasm, including any of the following subtypes: * Liposarcomas * Fibrosarcoma, myxofibrosarcoma * Undifferentiated pleomorphic sarcoma * Leiomyosarcomas * Pleomorphic rhabdomyosarcomas only * Angiosarcomas * Uncertain differentiated tumors: synovial sarcomas, epithelioid sarcomas, alveolar sarcomas, clear cells sarcomas. or osteosarcoma diagnosis, chondrosarcoma or chordoma. 3. Locally advanced or locally recurrent inoperable tumor without previous irradiation \[inoperable status must be assessed by staff including a surgeon specialized in sarcoma\]. 4. No prior treatment by sunitinib malate 5. Life expectancy \> 6 months 6. ECOG performance status ≤ 2 7. Blood tests, renal and liver functions in the normal range with, in the 7 days prior to study entry, blood or serum values as follows: * Absolute neutrophil count ≥ 1.,5 G/L * Platelet count ≥ 100 G/L * Bilirubin ≤ 1.5 mg/dL * PT and INR ≤ 1.5 times upper limit of normal \[Patients under preventive anticoagulant therapy are allowed to participate\] * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine ≤ 150 umol/L * Calcium ≤ 12 mg/dL * Blood glucose \< 150 mg/dL 8. Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study therapy 9. Ability to swallow oral medications 10. Mandatory affiliation with a health insurance company 11. Signed written informed consent. Exclusion Criteria: 1. GIST, Ewing sarcoma or embryonic rhabdomyosarcomas 2. Radiation field including lung, bowel, or central nervous system 3. Pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite medication 4. NCI grade ≥ 3 hemorrhage within the past 4 weeks prior to study drug administration 5. Significant cardiovascular disease (New York Heart Association (NYHA) \> grade 2 congestive cardiac failure, myocardial infarction within 6 months prior to inclusion, unstable angina, severe cardiac arrhythmia, severe cerebrovascular accident within 6 months prior to inclusion, history of severe thromboembolism (pulmonary embolism or deep vein thrombosis DVT) within 6 months prior to inclusion (patients with recent history of DVT treated by anticoagulant (except therapeutic warfarin)during at least 6 weeks are eligibles), prolonged QTc interval (QTc \> 480 msec with Bazett), bradycardia (heart rate \< 45bpm), electrolytic troubles (hyponatremia\<120mmol/l, kalemia≥6mmol/l) or uncontrolled hypertension while receiving appropriate medication (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic). 6. Less than 6 weeks between prior neoplastic treatment by tyrosine kinase inhibitor and inclusion and less than 4 weeks for other neoplastic treatments 7. Major surgical procedure, open biopsy, or serious non healing wound within 28 days prior to first day of treatment 8. Concurrent participation in another clinical trial 9. Other disease or illness within the past 6 months prior to study drug administration, including the following: * Psychiatric illness or social situation that would preclude study compliance * Known human immunodeficiency virus (HIV)- or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection 10. Known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease 11. peritoneal carcinosis 12. number of metastatic sites \> 2 13. Restriction of freedom by judicial or administrative decision 14. Pregnant or lactating women
References
Publications (41)
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- BACKGROUNDZagars GK, Ballo MT. Significance of dose in postoperative radiotherapy for soft tissue sarcoma. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):473-81. doi: 10.1016/s0360-3016(02)04573-x. PMID 12738323
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- BACKGROUNDSchmitt G, Pape H, Zamboglou N. Long term results of neutron- and neutron-boost irradiation of soft tissue sarcomas. Strahlenther Onkol. 1990 Jan;166(1):61-2. PMID 2154050
- BACKGROUNDAlektiar KM, Brennan MF, Healey JH, Singer S. Impact of intensity-modulated radiation therapy on local control in primary soft-tissue sarcoma of the extremity. J Clin Oncol. 2008 Jul 10;26(20):3440-4. doi: 10.1200/JCO.2008.16.6249. PMID 18612160
- BACKGROUNDDonnay L, Dejean C, Amsellem E, Bourezgui H, de Figueiredo BH, Duparc A, Caron J, Tournat H, Lagarde P, Stoeckle E, Kantor G. [Radiotherapy for soft tissue sarcomas of extremities. Preliminary comparative dosimetric study of 3D conformal radiotherapy versus helical tomotherapy]. Cancer Radiother. 2008 Dec;12(8):809-16. doi: 10.1016/j.canrad.2008.08.275. Epub 2008 Nov 28. French.