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Retreatment of Recurrent Tumors Using Proton Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Tumors

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Trial Information

Retreatment of Recurrent Tumors Using Proton Therapy


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.


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.

Type of Study:

Interventional

Study Design:

N/A

Outcome Measure:

Feasibility

Outcome Description:

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.

Outcome Time Frame:

90 days

Safety Issue:

No

Principal Investigator

John Plastaras, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 23309

NCT ID:

NCT01126476

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Tumors
  • Adults with non-CNS recurrent tumors who have been previously irradiated
  • and have a tumor recurrence in or near prior radiation fields

Name

Location
Procure Oklahoma City, Oklahoma  73142
Abamson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104
ProCure Proton Therapy Center Warrenville, Illinois  60555