Bevacizumab and Radiation Therapy for Sarcomas
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| ClinicalTrials.gov Identifier: NCT00356031 |
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Recruitment Status :
Completed
First Posted : July 25, 2006
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
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Sponsor:
Massachusetts General Hospital
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yen-Lin Evelyn Chen, MD, Massachusetts General Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Soft Tissue Sarcoma Fibrous Histiocytoma Liposarcoma Leiomyosarcoma Fibrosarcoma Synovial Sarcoma | Drug: Bevacizumab Radiation: Radiation Therapy Procedure: Surgery | Phase 2 |
- 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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas |
| Study Start Date : | July 2006 |
| Actual Primary Completion Date : | March 2010 |
| Actual Study Completion Date : | March 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Soft Tissue Sarcoma
Drug Information available for:
Bevacizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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)
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Drug: Bevacizumab
Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Other Name: Avastin Radiation: Radiation Therapy External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good. Procedure: Surgery Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy. |
Primary Outcome Measures :
- 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 Outcome Measures :
- Change in Median Microvessel Density (MVD) After Bevacizumab Alone [ Time Frame: baseline and 3 years ]The percentage change in median microvessel density (MVD) after Bevacizumab treatment alone
- Average Change in Blood Flow, Blood Volume,and Permeability Surface Area [ Time Frame: 3 years ]The percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.
- Local Control Rate [ Time Frame: 3 years ]The number of patients with local recurrence after a median follow-up of 24 months. Local recurrence is defined as disease progression (new cancer growth) at the primary cancer site.
- Distant Recurrence [ Time Frame: 3 years ]The number of participants with distant recurrence at the time of last follow-up. Distant recurrence is when cancer has spread (metastasized) to areas farther away from where the primary cancer site is.
- Disease Free Survival [ Time Frame: 3 years ]The median amount of time from the end of treatment until to distant recurrence. Distant recurrence is when cancer spreads to areas in the body away from the primary cancer site.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356031
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Yen-Lin Chen, MD | Massachusetts General Hospital |
Publications of Results:
| Responsible Party: | Yen-Lin Evelyn Chen, MD, Study Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00356031 History of Changes |
| Other Study ID Numbers: |
05-090 1R21CA117128-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 25, 2006 Key Record Dates |
| Results First Posted: | May 19, 2017 |
| Last Update Posted: | May 19, 2017 |
| Last Verified: | April 2017 |
Keywords provided by Yen-Lin Evelyn Chen, MD, Massachusetts General Hospital:
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Avastin |
Additional relevant MeSH terms:
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Sarcoma Leiomyosarcoma Liposarcoma Sarcoma, Synovial Fibrosarcoma Histiocytoma Histiocytoma, Benign Fibrous Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Muscle Tissue |
Neoplasms, Adipose Tissue Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |