Proton Radiotherapy for Recurrent Tumors

This study is currently recruiting participants.

Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania

Sponsor:

Collaborators:

Procure, Oklahoma City, OK

ProCure Proton Therapy Center, Warrenville, IL

Information provided by (Responsible Party):

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01126476

First received: May 17, 2010

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 17, 2010

Last Updated Date

February 26, 2013

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility [ Time Frame: 90 days ] [ Designated as safety issue: No ]
The study is infeasible if patient cannot be given treatment. Patient is unable to tolerate 15% treatment. patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion.
Acute Toxicity [ Time Frame: within 90 days ] [ Designated as safety issue: Yes ]
Acuite Toxicity is defined as any grade 4 toxicity observed within 90 days from the initiation of radiotherapy that is felt to be directly related to their proton treatment. Toxicities will be graded by NCI CTC Version 4.0

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01126476 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Late toxicity [ Time Frame: open-ended ] [ Designated as safety issue: Yes ]

Late toxicty is defined as any grade 3 or higher toxicty observed later than 90 days from start of therapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Proton Radiotherapy for Recurrent Tumors

Official Title ^ICMJE

Retreatment of Recurrent Tumors Using Proton Therapy

Brief Summary

The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies.

Detailed Description

Patients will be stratified by treatment site (Head and Neck, Thorax, Abdomen, Pelvis, Extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. This study will be done in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Tumors

Intervention ^ICMJE

Other: Proton Radiotherapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with histologically confirmed, non-CNS solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. Re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence.
Patients must have a Karnofsky Performance Status of 60. Life expectancy of 3 months .
Age greater or equal to 18.
Patients must be able to provide informed consent.
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.

Exclusion Criteria:

Prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume.
Pregnant women, women planning to become pregnant and women that are nursing.
Actively being treated on any research study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: John Plastaras, MD, PhD

855-216-0098

PennCancerTrials@emergingmed.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01126476

Other Study ID Numbers ^ICMJE

UPCC 23309

Has Data Monitoring Committee

Yes

Responsible Party

Abramson Cancer Center of the University of Pennsylvania

Study Sponsor ^ICMJE

Abramson Cancer Center of the University of Pennsylvania

Collaborators ^ICMJE

Procure, Oklahoma City, OK
ProCure Proton Therapy Center, Warrenville, IL

Investigators ^ICMJE

Principal Investigator:	John Plastaras, MD, PhD	Abramson Cancer Center of the University of Pennsylvania
Principal Investigator:	Marcio Fagundes, MD	Procure, Oklahoma City, OK
Principal Investigator:	William F. Hartsell, MD	ProCure Proton Therapy Center, Warrenville, IL

Information Provided By

Abramson Cancer Center of the University of Pennsylvania

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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