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Completed

NCT Number: NCT01126476

Proton Radiotherapy for Recurrent Tumors

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

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Key information

Conditions

Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ProCure Proton Therapy Center, Warrenville, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proton Radiotherapy

Other

Primary outcomes

  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:

    • Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
    • 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).
    • 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Retreatment of Recurrent Tumors Using Proton Therapy

Important dates

Study start
2010
Primary completion
2017
Study completion
2020
First posted
May 19, 2010
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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