Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma

Official Title: “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.

Intervention(s) in this Clinical Trial

• Radiation: Proton therapy
  • 28 daily fractions of 1.8 CGE/fx for total of 50.4 CGE over 5.5 weeks.
• Procedure: Resection
  • Resection of tumor at 4-6 weeks post-treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Proton Therapy

Primary Measures

• To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma.
  • Time Frame: 4-6 weeks post treatment
    Safety Issue?: No

Secondary 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.
    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
    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
    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
    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
    Safety Issue?: No

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 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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Florida Other

Overall Clinical Trial Officials and Contacts

Daniel J Indelicato, MD Principal Investigator University of Florida Proton Therapy Institute  

Overall Contact: Intake Coordinator (877) 686-6009 

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00901836

Study ID Number: UFPTI 0805-SA03

ClinicalTrials.gov Identifier: NCT00901836

Health Authority: United States: Institutional Review Board

Contact the University of Florida Proton Therapy Institute