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A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas

Phase 2
18 Years
Open (Enrolling)
Soft Tissue Sarcoma, Fibrous Histiocytoma, Liposarcoma, Leiomyosarcoma, Fibrosarcoma, Synovial Sarcoma

Thank you

Trial Information

A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas

- 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

- 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

- 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.

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

- 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

- 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 CNS disease

- Serious, non-healing wound, ulcer, or bone fracture

- Clinically significant cardiovascular disease, 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate for neoadjuvant bevacizumab combined with radiation therapy for intermediate and high-risk soft tissue sarcomas.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Yen-Lin Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

March 2010

Related Keywords:

  • Soft Tissue Sarcoma
  • Fibrous Histiocytoma
  • Liposarcoma
  • Leiomyosarcoma
  • Fibrosarcoma
  • Synovial Sarcoma
  • Avastin
  • Histiocytoma
  • Fibrosarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Sarcoma, Synovial
  • Histiocytoma, Benign Fibrous
  • Sarcoma



Massachusetts General Hospital Boston, Massachusetts  02114-2617