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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02701153
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : March 4, 2022
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

Tracking Information
First Submitted Date  ICMJE March 2, 2016
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date March 4, 2022
Actual Study Start Date  ICMJE February 3, 2016
Estimated Primary Completion Date February 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • Distant metastasis [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
  • Local failure [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used.
  • Overall survival [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
  • Progression free survival [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
  • Regional failure [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • Distant metastasis [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
  • Local control [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used.
  • Overall survival [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
  • Progression free survival [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
  • Regional control [ Time Frame: Up to 3 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
Official Title  ICMJE Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Adult Soft Tissue Sarcoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Conventional Surgery
  • Radiation: Hypofractionated Radiation Therapy
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2016)		 51
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 3, 2024
Estimated Primary Completion Date February 3, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jackie Hernandez 310-206-8477 ext 97624 jhernandez@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02701153
Other Study ID Numbers  ICMJE 15-001657
NCI-2016-00202 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15-001657 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jonsson Comprehensive Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Radiological Society of North America
  • Sarcoma Alliance for Research through Collaboration
  • Sarcoma Foundation of America
  • Tower Cancer Research Foundation
Investigators  ICMJE
Principal Investigator: Anusa Kalbasi, MD UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP