Clinical trial NCT00901836: Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma
Official title: A Pilot Study Investigating Preoperative Proton Radiotherapy for Retroperitoneal Sarcoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retroperitoneal Sarcoma
Keywords: Sarcoma
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-05-14
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: To assess treatment feasibility of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma.
timeFrame: 4-6 weeks post treatment
Secondary outcomes:
measure: To evaluate the acute and late toxicity of preoperative proton therapy for resectable intermediate or high grade retroperitoneal sarcoma
timeFrame: Weekly during treatment, then every 3 months for 1 year, then every 6 months for 4 years.
measure: To determine the incidence of margin negative resection in patients compared to historic controls treated with photon therapy.
timeFrame: 4-6 weeks post treatment
measure: To determine the percent tumor necrosis and percent apoptosis compared to historic controls treated with photon therapy.
timeFrame: 4-6 weeks post treatment
measure: To assess the predictive value of CT and MRI in evaluating pathologic tumor response and margin negative resection following proton radiotherapy.
timeFrame: 4-6 weeks post treatment
measure: 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.
timeFrame: 4-6 weeks post treatment
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Daniel J Indelicato, MD
role: PRINCIPAL_INVESTIGATOR
References:
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