Clinical trial NCT01126476: Proton Radiotherapy for Recurrent Tumors
Official title: Retreatment of Recurrent Tumors Using Proton Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumors
Keywords: Adults with non-CNS recurrent tumors who have been previously irradiated
and have a tumor recurrence in or near prior radiation fields
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of proton therapy
timeFrame: 90 days
measure: Acute Toxicity
timeFrame: within 90 days
Secondary outcomes:
measure: Late toxicity
timeFrame: open-ended
Other outcomes:
Locations:
city: Warrenville
country: United States
facility: ProCure Proton Therapy Center
state: Illinois
city: Oklahoma City
country: United States
facility: Procure
state: Oklahoma
city: Philadelphia
country: United States
facility: Abamson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: John Plastaras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Procure, Oklahoma City, OK
name: Marcio Fagundes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ProCure Proton Therapy Center, Warrenville, IL
name: William F. Hartsell, MD
role: PRINCIPAL_INVESTIGATOR
References: