Proton Radiotherapy for Recurrent Tumors

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention
Tumors
Other: Proton Radiotherapy

Study Type: Interventional
Official Title: Retreatment of Recurrent Tumors Using Proton Therapy

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: February 2010
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126476

Contacts
Contact: John Plastaras, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Illinois
ProCure Proton Therapy Center Recruiting
Warrenville, Illinois, United States
Contact: Lori Abruscato, BS    630-821-6397    lori.abruscato@chi.procure.com   
Principal Investigator: William R. Hartsell, MD         
United States, Oklahoma
Procure Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Marcio Fagundes, MD    405-720-3910    marcio.fagundes@okcprotons.com   
Principal Investigator: Marcio Fagundes, MD         
United States, Pennsylvania
Abamson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: John Plastaras, MD, PhD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: John Plastaras, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Procure, Oklahoma City, OK
ProCure Proton Therapy Center, Warrenville, IL
Investigators
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
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01126476     History of Changes
Other Study ID Numbers: UPCC 23309
Study First Received: May 17, 2010
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Adults with non-CNS recurrent tumors who have been previously irradiated
and have a tumor recurrence in or near prior radiation fields

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014