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Proton Radiotherapy for Recurrent Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01126476
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : April 24, 2020
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Tumors Other: Proton Radiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Retreatment of Recurrent Tumors Using Proton Therapy
Actual Study Start Date : February 2010
Actual Primary Completion Date : February 2017
Actual Study Completion Date : April 2020

Arm Intervention/treatment
Active Comparator: small volume strata
12 in small volume strata
Other: Proton Radiotherapy
Active Comparator: large volume strata
12 in large volume strata
Other: Proton Radiotherapy

Primary Outcome Measures :
  1. Feasibility of proton therapy [ Time Frame: 90 days ]

    To determine if the study is infeasible, defined if greater than 10% of pts experience one of the following:

    1. Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
    2. Patient who receives 15% or more of their treatments (for any reason, i.e. unable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using photon radiotherapy (i.e. up to 15% of treatments could be delivered using photons).
    3. Patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion or requires a treatment break greater than 5 days.

  2. Acute Toxicity [ Time Frame: within 90 days ]
    Acute 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 :
  1. Late toxicity [ Time Frame: open-ended ]
    Late toxicity is defined as any grade 3 or higher toxicity observed later than 90 days from start of therapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01126476

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United States, Illinois
ProCure Proton Therapy Center
Warrenville, Illinois, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73142
United States, Pennsylvania
Abamson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
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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
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01126476    
Other Study ID Numbers: UPCC 23309
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
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:
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Disease Attributes
Pathologic Processes