NCT00356031 · REGISTRY CONDITION SEARCH

Bevacizumab and Radiation Therapy for Sarcomas

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-05-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Change in Median Microvessel Density (MVD) After Bevacizumab Alone

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outcome · POSTED

Average Change in Blood Flow, Blood Volume,and Permeability Surface Area

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outcome · POSTED

Local Control Rate

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outcome · POSTED

Distant Recurrence

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outcome · POSTED

Disease Free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
intervention Names
Drug: Bevacizumab
Radiation: Radiation Therapy
Procedure: Surgery
label
Bevacizumab, Radiation, and Surgery
type
EXPERIMENTAL

interventions

arm Group Labels
Bevacizumab, Radiation, and Surgery
description
Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
name
Bevacizumab
other Names
Avastin
type
DRUG
arm Group Labels
Bevacizumab, Radiation, and Surgery
description
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.
name
Radiation Therapy
type
RADIATION
arm Group Labels
Bevacizumab, Radiation, and Surgery
description
Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.
name
Surgery
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 20
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.
measure
Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
time Frame
3 years

secondary Outcomes

description
The percentage change in median microvessel density (MVD) after Bevacizumab treatment alone
measure
Change in Median Microvessel Density (MVD) After Bevacizumab Alone
time Frame
baseline and 3 years
description
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.
measure
Average Change in Blood Flow, Blood Volume,and Permeability Surface Area
time Frame
3 years
description
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.
measure
Local Control Rate
time Frame
3 years
description
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.
measure
Distant Recurrence
time Frame
3 years
description
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.
measure
Disease Free Survival
time Frame
3 years

Full study description

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.
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.

Source references

references

citation
Yoon SS, Duda DG, Karl DL, Kim TM, Kambadakone AR, Chen YL, Rothrock C, Rosenberg AE, Nielsen GP, Kirsch DG, Choy E, Harmon DC, Hornicek FJ, Dreyfuss J, Ancukiewicz M, Sahani DV, Park PJ, Jain RK, Delaney TF. Phase II study of neoadjuvant bevacizumab and radiotherapy for resectable soft tissue sarcomas. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1081-90. doi: 10.1016/j.ijrobp.2010.07.024. Epub 2010 Oct 6.
pmid
20932656
type
RESULT
citation
Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.
pmid
32827353
type
DERIVED

Source notices and limitations

Discovery and provenance

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exact text
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start
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offset unit
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query cond
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query disease state id
ds-histiocytoma
source file
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source url
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Preserved source evidence · Not medical advice