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Bevacizumab and Radiation Therapy for Sarcomas

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yen-Lin Evelyn Chen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00356031
First received: July 21, 2006
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Soft Tissue Sarcoma
Fibrous Histiocytoma
Liposarcoma
Leiomyosarcoma
Fibrosarcoma
Synovial Sarcoma
Drug: Bevacizumab
Radiation: Radiation Therapy
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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.


Enrollment: 20
Study Start Date: July 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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 ( US NIH Grant/Contract Award Number )
Study First Received: July 21, 2006
Results First Received: February 16, 2017
Last Updated: April 14, 2017

Keywords provided by Massachusetts General Hospital:
Avastin

Additional relevant MeSH terms:
Sarcoma
Leiomyosarcoma
Liposarcoma
Fibrosarcoma
Histiocytoma
Histiocytoma, Benign Fibrous
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017