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A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma

Phase 2
18 Years
Not Enrolling
Retroperitoneal Sarcoma

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Trial Information

A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma.

Outcome Time Frame:

4-6 weeks post treatment

Safety Issue:


Principal Investigator

Daniel J Indelicato, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute


United States: Institutional Review Board

Study ID:

UFPTI 0805-SA03



Start Date:

May 2009

Completion Date:

November 2012

Related Keywords:

  • Retroperitoneal Sarcoma
  • Sarcoma
  • Sarcoma



University of Florida Proton Therapy InstituteJacksonville, Florida  32206