Clinical trial · Interventional
Bevacizumab and Radiation Therapy for Sarcomas
A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas
- 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 main purpose of this study is to test the effectiveness of bevacizumab in combination with radiation therapy to see what effects (good or bad) they have on patients with soft tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab in combination with radiation for sarcomas is still under investigation.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibrosarcoma | Fibrosarcoma | ONTOLOGY_EXACT | 0.90 |
| Fibrous Histiocytoma | Fibrous Histiocytoma | ONTOLOGY_EXACT | 0.98 |
| Leiomyosarcoma | Leiomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Liposarcoma | Liposarcoma | ONTOLOGY_EXACT | 0.90 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Synovial Sarcoma | Synovial Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab, Radiation, and Surgery
- description
- Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
- interventionNames
- Drug: Bevacizumab
- Radiation: Radiation Therapy
- Procedure: Surgery
Primary outcomes (1)
- measure
- Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
- timeFrame
- 3 years
- description
- The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary soft tissue sarcoma (STS) or an isolated local recurrence of STS. Open incisional biopsy or core biopsies should be performed within 8 weeks prior to registration * Tumor grade of intermediate or high grade * Tumor must be located on the upper extremity, the lower extremity, trunk, retroperitoneum, or pelvis * Primary tumors must be \> 5.0cm in maximal diameter and local recurrence can be any size * 18 years of age or older * Zubrod performance status of 0-2 * Adequate organ and marrow function Exclusion Criteria: * Metastatic disease * Pregnant or lactating women * HIV positive patients * Prior treatment with radiation, chemotherapy or biotherapy for this tumor * History or evidence of central nervous system (CNS) disease * Serious, non-healing wound, ulcer, or bone fracture * Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year * History of stroke within the past 6 months * Major surgical procedure or significant traumatic injury within 28 days * Current or recent (within 10 days) use of full-dose oral or parenteral anticoagulants or thrombolytic agents. * Presence of bleeding diathesis or coagulopathy * Proteinuria at baseline or clinically significant impairment of renal function * History of abdominal fistula, gastrointestinal perforation, or inta-abdominal abscess within the past 6 months * Documented history of uncontrolled seizures * Grade 2 or greater sensory neuropathy based upon the NCI CTCAE, version 3.0 * Known history of deep vein thrombosis or pulmonary embolus * Known hypercoagulable disorder * History of hepatic cirrhosis or current hepatic dysfunction
References
Publications (2)
- RESULTYoon SS, Duda DG, Karl DL, Kim TM, Kambadakone AR, Chen YL, Rothrock C, Rosenberg AE, Nielsen GP, Kirsch DG, Choy E, Harmon DC, Hornicek FJ, Dreyfuss J, Ancukiewicz M, Sahani DV, Park PJ, Jain RK, Delaney TF. Phase II study of neoadjuvant bevacizumab and radiotherapy for resectable soft tissue sarcomas. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1081-90. doi: 10.1016/j.ijrobp.2010.07.024. Epub 2010 Oct 6. PMID 20932656
- DERIVEDVatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22. PMID 32827353