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SA02: Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas

Sponsor
University of Florida (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00881595
Collaborator
(none)
0
Enrollment
3
Arms
45
Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this study is to evaluate the effects of temozolomide and radiation combination in the treatment intended of soft tissue sarcomas.

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 soft tissue sarcoma in the future. In addition the investigators will examine a sample of your normal tissue (optional) from the inside of your mouth/cheek (to compare it to your tumor tissue) before starting treatment.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chemoradiotherapy Temozolomide
  • Radiation: Proton therapy
  • Procedure: Proton Chemoradiotherapy followed by surgery
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study Investigating Neoadjuvant Temozolomide-based Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: Proton Chemoradiotherapy followed by surgery

Proton Chemoradiotherapy followed by surgery. Temozolomide five days per week during radiotherapy for 5 weeks. Proton radiation five days per week for 5 weeks Standard surgery will take place 4-6 weeks after completion of chemoradiation.

Procedure: Proton Chemoradiotherapy followed by surgery
Proton Chemoradiotherapy followed by surgery. Resection of tumor at 4-6 weeks post-treatment.
Active Comparator: Chemoradiotherapy Temozolomide

Chemoradiotherapy Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks. Temozolomide should be taken orally 1 hour before each session of radiotherapy during weekdays (Monday through Friday). The dose will be determined using the body surface area (BSA) calculated at the beginning of the concurrent treatment. The BSA will be calculated from the height obtained at the pretreatment visit and the weight obtained before the first day of treatment. The concurrent treatment will last until the end of radiotherapy.

Drug: Chemoradiotherapy Temozolomide
Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks.Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks. Temozolomide should be taken orally 1 hour before each session of radiotherapy during weekdays (Monday through Friday). The dose will be determined using the body surface area (BSA) calculated at the beginning of the concurrent treatment. The BSA will be calculated from the height obtained at the pretreatment visit and the weight obtained before the first day of treatment. The concurrent treatment will last until the end of radiotherapy.
Other Names:
  • Temozolomide
  • Temodar

    		•
    Active Comparator: Proton Therapy

    50 cobalt gray equivalent(CGE), 25 daily fractions, 5 weeks (2 CGE/fx)

    Radiation: Proton therapy
    50 cobalt gray equivalent(CGE), 25 daily fractions, 5 weeks (2 CGE/fx)
    Other Names:
  • Radiation therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assess treatment feasibility of neoadjuvant temozolomide-based proton chemoradiotherapy for high-risk soft tissue sarcoma [6 months after surgery then every 6 months for 3 years]

    Secondary Outcome Measures

    1. Evaluate acute and late toxicities [Weekly during treatment, 6 months after surgery, then every 6 months for 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have histologic and radiographic proof of localized high-risk soft tissue sarcoma (STS) required prior to registration.

    • For the purpose of this study, high risk STS is defined by at least two of the following risk factors:

    • Tumor ≥ 5 cm in maximal diameter on MRI or CT

    • Histology grade 3 or 4 (AJCC, 7th edition)

    • Tumor deep to the investing fascia

    • Locally recurrent sarcoma with no prior radiation therapy to the primary site

    • Age >55 years old

    • Tumor must be considered potentially resectable as defined by cross sectional imaging.

    • 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.

    • Physician documented life expectancy of greater than 3 months.

    • Patients must have normal organ and marrow function within 4 weeks prior to study treatment as defined below:

    • hemoglobin ≥ 9 g/dL

    • leukocytes ≥3,000/microliter (mcL)

    • absolute neutrophil count ≥1,500/mcL

    • platelets ≥100,000/mcL

    • total bilirubin ≤ institutional upper limit of normal

    • aspartate aminotransferase (AST/SGOT) and alanine aminotransferase(ALT/SGPT) < 2.5 x institutional upper limit of normal

    • creatinine within 1.5 x upper limit of normal(ULN)

    • Women of child-bearing 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 for 12 months after treatment. Patients must have a negative serum pregnancy test within 14 days 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 prior to any research related procedures or study treatment.

    Exclusion Criteria:

    • Receiving any investigational agents.

    • Treatment with cytotoxic agents and/or treatment with biologic agents within the 4 weeks prior to beginning treatment on this study.

    • Evidence of metastatic disease.

    • Previous radiotherapy to the affected site.

    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and/or psychiatric illness/social situations that would limit compliance with study requirements.

    • Pregnant women are excluded from this study because the investigational agents 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.

    • HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents.

    • All herbal and/or alternative medications should be discontinued while on study, these include but are not limited to: Hydrastis canadensis (goldenseal), Uncaria tomentosa (cat's claw) or Echinacea angustifolia.

    • Requirement for treatment with immunosuppressive agents or chronic steroids.

    • A history of a hypersensitivity reaction to any of temozolomide's components or to Dacarbazine(DTIC).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Florida

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT00881595
    Other Study ID Numbers:
    • UFPTI 0803-SA02
    First Posted:
    Apr 15, 2009
    Last Update Posted:
    Feb 10, 2017
    Last Verified:
    Feb 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of Florida
    Sarcomas
    High-Risk Soft Tissue Sarcomas
    Additional relevant MeSH terms:
    Sarcoma
    Temozolomide

    Study Results

    No Results Posted as of Feb 10, 2017