Proton Radiotherapy for Recurrent Tumors
This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Collaborators:
Procure, Oklahoma City, OK
ProCure Proton Therapy Center, Warrenville, IL
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01126476
First received: May 17, 2010
Last updated: February 26, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies.
| Condition | Intervention |
|---|---|
|
Tumors |
Other: Proton Radiotherapy |
| Study Type: | Interventional |
| Official Title: | Retreatment of Recurrent Tumors Using Proton Therapy |
Resource links provided by NLM:
Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:
Primary Outcome Measures:
- Feasibility [ Time Frame: 90 days ] [ Designated as safety issue: No ]The study is infeasible if patient cannot be given treatment. Patient is unable to tolerate 15% treatment. patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion.
- Acute Toxicity [ Time Frame: within 90 days ] [ Designated as safety issue: Yes ]Acuite 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 [ Time Frame: open-ended ] [ Designated as safety issue: Yes ]Late toxicty is defined as any grade 3 or higher toxicty observed later than 90 days from start of therapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system.
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126476
Contacts
| Contact: John Plastaras, MD, PhD | 855-216-0098 | PennCancerTrials@emergingmed.com |
Locations
| United States, Illinois | |
| ProCure Proton Therapy Center | Recruiting |
| Warrenville, Illinois, United States | |
| Contact: Lori Abruscato, BS 630-821-6397 lori.abruscato@chi.procure.com | |
| Principal Investigator: William R. Hartsell, MD | |
| United States, Oklahoma | |
| Procure | Recruiting |
| Oklahoma City, Oklahoma, United States, 73142 | |
| Contact: Marcio Fagundes, MD 405-720-3910 marcio.fagundes@okcprotons.com | |
| Principal Investigator: Marcio Fagundes, MD | |
| United States, Pennsylvania | |
| Abamson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: John Plastaras, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com | |
| Principal Investigator: John Plastaras, MD | |
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Procure, Oklahoma City, OK
ProCure Proton Therapy Center, Warrenville, IL
Investigators
| Principal Investigator: | John Plastaras, MD, PhD | Abramson Cancer Center of the University of Pennsylvania |
| Principal Investigator: | Marcio Fagundes, MD | Procure, Oklahoma City, OK |
| Principal Investigator: | William F. Hartsell, MD | ProCure Proton Therapy Center, Warrenville, IL |
More Information
No publications provided
| Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01126476 History of Changes |
| Other Study ID Numbers: | UPCC 23309 |
| Study First Received: | May 17, 2010 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
|
Adults with non-CNS recurrent tumors who have been previously irradiated and have a tumor recurrence in or near prior radiation fields |
ClinicalTrials.gov processed this record on May 22, 2013