Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma (SA03)

February 9, 2017 updated by: University of Florida

A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma

The goal of this study is to evaluate radiation treatment intended to increase the chance of curing your sarcoma and decrease the side effects of proton therapy.

This study will also look at the tumor tissue that was removed during your initial biopsy and your final surgery for information that may help to treat retroperitoneal sarcoma in the future.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Proton Therapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients must have histologically-confirmed intermediate or high grade retroperitoneal sarcomas of any histologic subtype.
  • Primary or recurrent disease isolated to a single intra-abdominal or retroperitoneal region is allowed.
  • Tumor must be considered potentially completely resectable as defined by cross sectional imaging (no 360o encasement of the superior mesenteric artery, aorta, inferior vena cava, iliac arteries or iliac veins and no extension of tumor into the vertebral column).
  • At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Patients must have ≤ grade 1 acute toxicities of any prior treatment with anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤ grade 1 are eligible.
  • Age ≥18 years at time of consent.
  • Life expectancy of greater than 3 months. Physician documented.
  • Women of child-producing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and the subsequent 6 months. Patients must have a negative serum pregnancy test within 2 weeks prior to beginning treatment on this trial. Sexually active men must also use appropriate contraception method and should not father a child while receiving therapy during this study.
  • Ability to understand and the willingness to sign a written Institutional Review Board(IRB) stamped study specific informed consent document before undergoing research related procedures or study treatment.
  • Biopsy is required with pathologic confirmation of intermediate or high grade sarcoma with pathology review at the University of Florida.
  • Agree to allow their tissue to be used for current study.

Exclusion Criteria:

  • Receiving any investigational agents.
  • Evidence of metastatic disease.
  • Uncontrolled intercurrent illness and/or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and nursing women are excluded from this study because the radiotherapy may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated.
  • All herbal and/or alternative medications should be discontinued while on study, including, but not limited to: Hydrastis canadensis (goldenseal), Uncaria tomentosa (cat's claw) or Echinacea angustifolia.
  • Requirement for treatment with immunosuppressive agents or chronic steroids.
  • Previous intra-abdominal or retroperitoneal radiotherapy.
  • Treatment with cytotoxic agents and/or treatment with biologic agents within the 4 weeks prior to beginning treatment on this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative Proton Therapy
28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks.
Radiation: Preoperative proton therapy
28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks.
Active Comparator: Surgery
Standard of care surgery will be performed 4-6 weeks after the completion of radiation.
Procedure: Surgery
Standard of care surgery will be performed 4-6 weeks after completion of radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma.
Time Frame: 4-6 weeks post treatment
4-6 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the acute and late toxicity of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma
Time Frame: Weekly during treatment, then every 3 months for 1 year, then every 6 months for 4 years.
Weekly during treatment, then every 3 months for 1 year, then every 6 months for 4 years.
To determine the incidence of margin negative resection in patients compared to historic controls treated with photon therapy.
Time Frame: 4-6 weeks post treatment
4-6 weeks post treatment
To determine the percent tumor necrosis and percent apoptosis compared to historic controls treated with photon therapy.
Time Frame: 4-6 weeks post treatment
4-6 weeks post treatment
To assess the predictive value of CT and MRI in evaluating pathologic tumor response and margin negative resection following proton radiotherapy.
Time Frame: 4-6 weeks post treatment
4-6 weeks post treatment
To compare the dose distribution to tumor and surrounding normal structures using dose volume histograms (DVHs) generated from the proton plan used to treat the patient and a theoretical photon plan generated for comparison purposes.
Time Frame: 4-6 weeks post treatment
4-6 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 0805-SA03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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