Proton Radiotherapy for Recurrent Tumors

NCT01126476 | Completed DMC

• 1 other identifier: UPCC 23309
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of proton therapy

  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.

  90 days

• Acute Toxicity

  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

  within 90 days

Secondary Outcomes (1)

• Late toxicity

  open-ended

Study Arms (2)

small volume strata

ACTIVE COMPARATOR

12 in small volume strata

Other: Proton Radiotherapy

large volume strata

ACTIVE COMPARATOR

12 in large volume strata

Other: Proton Radiotherapy

Interventions

Proton Radiotherapy OTHER

large volume strata; small volume strata

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (3)

ProCure Proton Therapy Center

Warrenville, Illinois, United States

Location

Procure

Oklahoma City, Oklahoma, 73142, United States

Location

Abamson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• John Plastaras, MD, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

• Marcio Fagundes, MD

  Procure, Oklahoma City, OK

  PRINCIPAL INVESTIGATOR

• William F. Hartsell, MD

  ProCure Proton Therapy Center, Warrenville, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (3)