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Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

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ClinicalTrials.gov Identifier: NCT02701153
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : February 23, 2023
Sponsor:
Collaborators:
Radiological Society of North America
Sarcoma Alliance for Research through Collaboration
Sarcoma Foundation of America
Tower Cancer Research Foundation
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:
This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Condition or disease Intervention/treatment Phase
Recurrent Adult Soft Tissue Sarcoma Procedure: Conventional Surgery Radiation: Hypofractionated Radiation Therapy Other: Laboratory Biomarker Analysis Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJCETIVES:

I. Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.

SECONDARY OBJECTIVES:

I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.

II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).

III. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

IV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

OUTLINE:

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
Actual Study Start Date : February 3, 2016
Estimated Primary Completion Date : February 3, 2024
Estimated Study Completion Date : February 3, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
 Procedure: Conventional Surgery
Undergo surgery

Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) [ Time Frame: Up to 2 years ]
    Interim reports will be prepared every six months until the results of the study are published. In general, the interim reports will contain information about patient accrual rate with projected completion dates, status of question-answer (QA) review and compliance rate of treatment per protocol, and the frequencies and severity of toxicity.


Secondary Outcome Measures :
  1. Distant metastasis [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.

  2. Local failure [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used.

  3. Overall survival [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.

  4. Progression free survival [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.

  5. Regional failure [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed soft tissue sarcoma of the extremity/trunk
  • Intermediate or high grade sarcoma
  • Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
  • Recurrent, any grade, no previous radiation therapy
  • Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
  • If a woman is of childbearing potential, a negative serum pregnancy test must be documented

Exclusion Criteria:

  • Active treatment of a separate malignancy
  • History of prior irradiation to the area to be treated
  • Pre-operative chemotherapy (post-op acceptable)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701153


Contacts
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Contact: Jackie Hernandez 310-206-8477 ext 97624 jhernandez@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Vincent Basehart    310-267-8954    vbasehart@mednet.ucla.edu   
Principal Investigator: Anusa Kalbasi, M.D.         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Radiological Society of North America
Sarcoma Alliance for Research through Collaboration
Sarcoma Foundation of America
Tower Cancer Research Foundation
Investigators
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Principal Investigator: Anusa Kalbasi, MD UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02701153    
Other Study ID Numbers: 15-001657
NCI-2016-00202 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15-001657 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms