Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas (SA02)

This study has been withdrawn prior to enrollment.
(No patients accrued since study opened)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00881595
First received: April 13, 2009
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Soft Tissue Sarcomas
Drug: Chemoradiotherapy Temozolomide
Radiation: Proton therapy
Procedure: Proton Chemoradiotherapy followed by surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Investigating Neoadjuvant Temozolomide-based Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Assess treatment feasibility of neoadjuvant temozolomide-based proton chemoradiotherapy for high-risk soft tissue sarcoma [ Time Frame: 6 months after surgery then every 6 months for 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate acute and late toxicities [ Time Frame: Weekly during treatment, 6 months after surgery, then every 6 months for 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Proton Chemoradiotherapy followed by surgery
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 Name: Radiation therapy

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881595

Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Daniel J Indelicato, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Jemal A, Tiwari RC, Murray T et al. Cancer statistics, 2004. CA Cancer J Clin 2004;54:8-29.
Barkley HT, Jr., Martin RG, Romsdahl MM et al. Treatment of soft tissue sarcomas by preoperative irradiation and conservative surgical resection. Int J Radiat Oncol Biol Phys 1988;14:693-699.
O'Sullivan B, Chung P, Euler C, Catton C. Soft Tissue Sarcoma. In: Gunderson LL, Tepper JE, editors. Clinical Radiation Oncology, ed. 2nd. Philadelphia: Elsevier; 2007:1519-1549.
Nielsen OS, Cummings B, O'Sullivan B et al. Preoperative and postoperative irradiation of soft tissue sarcomas: effect of radiation field size. Int J Radiat Oncol Biol Phys 1991;21:1595-1599.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00881595     History of Changes
Other Study ID Numbers: UFPTI 0803-SA02
Study First Received: April 13, 2009
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Sarcomas
High-Risk Soft Tissue Sarcomas

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014