A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
Study Overview
Brief Summary
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.
Detailed Description
- The dose of bevacizumab and radiation therapy will be the same for all participants throughout the study.
- Bevacizumab will be given as an intravenous infusion every 2 weeks for a total of 4 doses.
- Radiation therapy will begin 2 weeks after the first bevacizumab infusion and will be delivered 5 days per week over a period of 6 weeks. This is done as an outpatient procedure. Each 2 week period will be considered a separate treatment cycle. Participants will be treated with radiation therapy for a maximum of 3 cycles (6 weeks).
- A surgeon will evaluate the participants tumor by radiologic studies before study treatment to determine if surgical removal is possible. After the completion of study treatment, a surgeon will repeat the evaluation of the tumor. Surgery will performed 6-7 weeks after the completion of radiation therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bevacizumab, Radiation, and Surgery
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Intervention: Bevacizumab (Drug)
Bevacizumab, Radiation, and Surgery
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Intervention: Radiation Therapy (Radiation)
Bevacizumab, Radiation, and Surgery
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Intervention: Surgery (Procedure)
Outcomes
Primary Outcomes
Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
Time Frame: 3 years
The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.
Secondary Outcomes
- Distant Recurrence(3 years)
- Disease Free Survival(3 years)
- Local Control Rate(3 years)
- Average Change in Blood Flow, Blood Volume,and Permeability Surface Area(3 years)
- Change in Median Microvessel Density (MVD) After Bevacizumab Alone(baseline and 3 years)
Investigators
Yen-Lin Evelyn Chen, MD
Study Principal Investigator
Massachusetts General Hospital