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Bevacizumab and Radiation Therapy for Sarcomas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356031
First Posted: July 25, 2006
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yen-Lin Evelyn Chen, MD, Massachusetts General Hospital
Results First Submitted: February 16, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Soft Tissue Sarcoma
Fibrous Histiocytoma
Liposarcoma
Leiomyosarcoma
Fibrosarcoma
Synovial Sarcoma
Interventions: Drug: Bevacizumab
Radiation: Radiation Therapy
Procedure: Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the multidisciplinary sarcoma clinic, surgical oncology, radiation oncology, and medical oncology clinics at the Massachusetts General Hospital, Brigham and Women’s Hospital, or Dana-Farber Cancer Institute.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses

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.

Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.


Participant Flow:   Overall Study
    Experimental: Bevacizumab, Radiation, and Surgery
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses

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.

Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy.


Baseline Measures
   Bevacizumab, Radiation, and Surgery 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      16  80.0% 
>=65 years      4  20.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  35.0% 
Male      13  65.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 
Sarcoma Histology 
[Units: Participants]
Count of Participants
 
Fibroblastic   8 
Liposarcoma   6 
Leiomyosarcoma   4 
Fibroblastic Osteosarcoma   1 
Not Otherwise Specified   1 
Sarcoma Grade 
[Units: Participants]
Count of Participants
 
Low   2 
Intermediate   8 
High   10 
Median Sarcoma Size 
[Units: Centimeters (cm)]
Median (Full Range)
 8.25 
 (5 to 20.2) 
Sarcoma Location 
[Units: Participants]
Count of Participants
 
Extremity   13 
Trunk   1 
retroperitoneal/pelvis tumors   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.   [ Time Frame: 3 years ]

2.  Secondary:   Change in Median Microvessel Density (MVD) After Bevacizumab Alone   [ Time Frame: baseline and 3 years ]

3.  Secondary:   Average Change in Blood Flow, Blood Volume,and Permeability Surface Area   [ Time Frame: 3 years ]

4.  Secondary:   Local Control Rate   [ Time Frame: 3 years ]

5.  Secondary:   Distant Recurrence   [ Time Frame: 3 years ]

6.  Secondary:   Disease Free Survival   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small number of patients. Results require validation in a larger cohort of patients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sam S. Yoon, Principal Investigator
Organization: Massachusetts General Hospital
phone: 617 643-9475
e-mail: syoon@partners.org


Publications of Results:

Responsible Party: Yen-Lin Evelyn Chen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00356031     History of Changes
Other Study ID Numbers: 05-090
1R21CA117128-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 21, 2006
First Posted: July 25, 2006
Results First Submitted: February 16, 2017
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017