Proton Radiotherapy for Extremity Soft Tissue Sarcoma

NCT01561495 | Terminated Phase 2 Results DMC

• 1 other identifier: UPCC 09510
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of proton radiotherapy for the pre- or post- operative treatment of patients with extremity sarcoma. This study will treat patients in two dose groups:

1. 1.patients receiving pre-operative proton therapy and
2. 2.patients receiving post-operative proton therapy. In each dose group, the study is divided into two phases. In the first phase of the study, the investigators will determine if treatment with proton therapy is safe and can be delivered on a regular basis. In the second phase, the investigators will determine if proton therapy has less long term side effects compared to standard radiation in both pre-operative patients and post-operative patients.

Conditions

Soft Tissue Sarcoma of the Extremities

Keywords

scheduled to receive RT either pre- or postoperatively

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Given this is initially a feasibility study- the primary measure is number of AEs (Adverse Events).

  4 years

Study Arms (1)

All Participants

EXPERIMENTAL

Proton Radiotherapy

Radiation: Proton Therapy

Interventions

Proton Therapy RADIATION

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a histologic diagnosis of soft tissue sarcoma of the extremities are eligible for this study.
• Patient must be 18 years of age.
• Patients must have evidence of disease limited to the extremities.
• For the pre-operative group, patients must be considered operable/resectable and a candidate for pre-operative radiotherapy as judged by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. All patients in the pre-operative group will be evaluated for this protocol PRIOR to the initiation of therapy.
• For the post-operative group, patients must be considered operable/resectable (if evaluated prior to resection) and a candidate for post-operative radiotherapy by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. Patients in the post-operative group may be evaluated PRIOR to the initiation of any therapy or may be referred for evaluation after surgical resection.
• ECOG status of 0-2.
• Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable to sign informed consent are excluded from the study.
• Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.
• Negative urine pregnancy test for females of childbearing potential on the day of the F18-EF5 PET scan prior to F18-EF5 injection

You may not qualify if:

• Pregnant women, women planning to become pregnant and women that are nursing.
• Patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19004, United States

Location

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Susan Prendergast, RN
• Organization: AbramsonCC Radiation Oncolocy

susan.prendergast@pennmedicine.upenn.edu

215-662-4267

Study Officials

• Curtiland Deville, MD

  Johns Hopkins Kimmel Cancer Center at Sibley Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: June 1, 2010
• Primary Completion: February 3, 2017
• Study Completion: February 3, 2017
• Last Updated: December 6, 2019
• Results First Posted: December 6, 2019

Record last verified: 2019-11

Locations

US (1)