Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma

NCT00901836 | Terminated DMC

• 1 other identifier: UFPTI 0805-SA03
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Retroperitoneal Sarcoma

Keywords

Sarcoma

Outcome Measures

Primary Outcomes (1)

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

  4-6 weeks post treatment

Secondary Outcomes (5)

• 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 incidence of margin negative resection in patients compared to historic controls treated with photon therapy.

  4-6 weeks post treatment

• To determine the percent tumor necrosis and percent apoptosis 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

• 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

Study Arms (2)

Preoperative Proton Therapy

EXPERIMENTAL

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

Surgery

ACTIVE COMPARATOR

Standard of care surgery will be performed 4-6 weeks after the completion of radiation.

Procedure: Surgery

Interventions

Preoperative proton therapy RADIATION

28 daily fractions of 1.8 cobalt gray equivalent(CGE)/fx for total of 50.4 CGE over 5.5 weeks.

Preoperative Proton Therapy

Surgery PROCEDURE

Standard of care surgery will be performed 4-6 weeks after completion of radiation.

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Sarcoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Daniel J Indelicato, MD

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)