Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma

Not Applicable

Terminated

• Conditions: Retroperitoneal Sarcoma
• Interventions: Radiation: Preoperative proton therapy; Procedure: Surgery

• Registration Number: NCT00901836
• Lead Sponsor: University of Florida

Brief Summary

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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-14
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma.	4-6 weeks post treatment

Secondary Outcome Measures

Name	Time	Method
To evaluate the acute and late toxicity of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma	Weekly during treatment, then every 3 months for 1 year, then every 6 months for 4 years.
To determine the percent tumor necrosis and percent apoptosis compared to historic controls treated with photon therapy.	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.	4-6 weeks post treatment
To determine the incidence of margin negative resection in patients compared to historic controls treated with photon therapy.	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.	4-6 weeks post treatment

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States