Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Liposarcoma

Fibrosarcoma

Histiocytoma

Histiocytoma, Benign Fibrous

Leiomyosarcoma

Sarcoma, Synovial

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Adipose Tissue

Neoplasms, Connective Tissue

Neoplasms, Fibrous Tissue

Soft Tissue Sarcoma

Synovial Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)

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

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.

Radiation Therapy

Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.

Surgery

Yen-Lin Chen, MD

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.

* 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.

Bevacizumab and Radiation Therapy for Sarcomas

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

The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.

The percentage change in median microvessel density (MVD) after Bevacizumab treatment alone

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.

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.

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.

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.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Massachusetts General Hospital

Study Principal Investigator

Laboratory tests and physical exams were performed as a part of routine study visits.

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.

Bevacizumab, Radiation, and Surgery

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Fibroblastic

Fibroblastic Osteosarcoma

Not Otherwise Specified

Sarcoma Histology

Intermediate

High

Sarcoma Grade

Median Sarcoma Size

Extremity

Trunk

retroperitoneal/pelvis tumors

Sarcoma Location

Small number of patients. Results require validation in a larger cohort of patients.

Dr. Sam S. Yoon, Principal Investigator

80-89% necrosis

90-99% necrosis

100% necrosis

Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.

Change in Median Microvessel Density (MVD) After Bevacizumab Alone

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

Spots Global Cancer Trial Database for Bevacizumab and Radiation Therapy for Sarcomas

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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