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Soft Tissue SarcomaPhase 2NCT00356031

Bevacizumab and Radiation Therapy for Sarcomas

A Phase 2 study testing Bevacizumab, Radiation Therapy and Surgery in people with Soft Tissue Sarcoma and Fibrous Histiocytoma, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Radiation Therapy and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2006to Mar 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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

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.

Read the 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.
Being tested
Bevacizumab, Radiation Therapy, Surgery
Keywords
Avastin
Medical subject headings
Sarcoma, Histiocytoma, Benign Fibrous, Liposarcoma, Leiomyosarcoma, Fibrosarcoma, Sarcoma, Synovial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

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

  • Radiation TherapyRadiation

    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.

  • SurgeryProcedure or surgery

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

Study groups in NCT00356031
Study groupRoleWhat they receive
Bevacizumab, Radiation, and SurgeryExperimentalBevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Receives: Drug: Bevacizumab; Radiation: Radiation Therapy; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 years

Secondary outcomes (5)

  1. Change in Median Microvessel Density (MVD) After Bevacizumab Alone

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

    Measured: baseline and 3 years

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

    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.

    Measured: 3 years

  3. Local Control Rate

    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.

    Measured: 3 years

  4. Distant Recurrence

    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.

    Measured: 3 years

  5. Disease Free Survival

    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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00356031
Sponsor's protocol ID
05-090
Other IDs
1R21CA117128-01A1
Status last verified
Apr 2017
First submitted
21 Jul 2006
Last updated
19 May 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20932656

  • 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.

    PubMed 32827353

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Radiation Therapy and Surgery in people with Soft Tissue Sarcoma and Fibrous Histiocytoma, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356031, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.

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