Proton Radiotherapy for Recurrent Tumors

Tumors Clinical Trial

Official title:

Retreatment of Recurrent Tumors Using Proton Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126476
• Other study ID #: UPCC 23309
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2020
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Tumors

Intervention

Other:
• Proton Radiotherapy

Locations

Country	Name	City	State
United States	Procure	Oklahoma City	Oklahoma
United States	Abamson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	ProCure Proton Therapy Center	Warrenville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of proton therapy	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.	90 days
Primary	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	Late toxicity	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.	open-ended