Proton Radiotherapy for Recurrent Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2020-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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small volume strata

12 in small volume strata

Group Type ACTIVE_COMPARATOR

Proton Radiotherapy

Intervention Type OTHER

large volume strata

12 in large volume strata

Group Type ACTIVE_COMPARATOR

Proton Radiotherapy

Intervention Type OTHER

Interventions

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Proton Radiotherapy

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No