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Proton Radiotherapy for Recurrent Tumors

Primary Purpose

Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Radiotherapy
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tumors focused on measuring Adults with non-CNS recurrent tumors who have been previously irradiated, and have a tumor recurrence in or near prior radiation fields

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ProCure Proton Therapy Center
  • Procure
  • Abamson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

small volume strata

large volume strata

Arm Description

12 in small volume strata

12 in large volume strata

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2010
Last Updated
April 23, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01126476
Brief Title
Proton Radiotherapy for Recurrent Tumors
Official Title
Retreatment of Recurrent Tumors Using Proton Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors
Keywords
Adults with non-CNS recurrent tumors who have been previously irradiated, and have a tumor recurrence in or near prior radiation fields

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
small volume strata
Arm Type
Active Comparator
Arm Description
12 in small volume strata
Arm Title
large volume strata
Arm Type
Active Comparator
Arm Description
12 in large volume strata
Intervention Type
Other
Intervention Name(s)
Proton Radiotherapy
Primary Outcome Measure Information:
Title
Feasibility of proton therapy
Description
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.
Time Frame
90 days
Title
Acute Toxicity
Description
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
Time Frame
within 90 days
Secondary Outcome Measure Information:
Title
Late toxicity
Description
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.
Time Frame
open-ended

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Plastaras, MD, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcio Fagundes, MD
Organizational Affiliation
Procure, Oklahoma City, OK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William F. Hartsell, MD
Organizational Affiliation
ProCure Proton Therapy Center, Warrenville, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProCure Proton Therapy Center
City
Warrenville
State/Province
Illinois
Country
United States
Facility Name
Procure
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73142
Country
United States
Facility Name
Abamson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Proton Radiotherapy for Recurrent Tumors

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