Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma (SA03)

This study has been terminated.
(Only 2 patients enrolled since study start, both have since died)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00901836
First received: May 13, 2009
Last updated: December 4, 2013
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Retroperitoneal Sarcoma
Radiation: Preoperative proton therapy
Procedure: Surgery
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma. [ Time Frame: 4-6 weeks post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine the percent tumor necrosis and percent apoptosis compared to historic controls treated with photon therapy. [ Time Frame: 4-6 weeks post treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: May 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901836

Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Daniel J Indelicato, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Tepper JE, Gunderson LL, Orlow E et al. Complications of intraoperative radiation therapy. Int J Radiat Oncol Biol Phys 1984;10:1831-1839.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00901836     History of Changes
Other Study ID Numbers: UFPTI 0805-SA03
Study First Received: May 13, 2009
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Sarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014