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Hypofractionated Radiation Therapy in Treating Patients With Recurrent Soft Tissue Sarcomas Before Surgery

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ClinicalTrials.gov Identifier: NCT02701153
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas that have come back before 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Hypofractionated Radiation Therapy for Soft Tissue Sarcomas
Actual Study Start Date : February 3, 2016
Estimated Primary Completion Date : February 3, 2020
Estimated Study Completion Date : February 3, 2021

Resource links provided by the National Library of Medicine


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




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.



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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)

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


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Mitchell R. Kamrava    310-825-9771    MKamrava@mednet.ucla.edu   
Principal Investigator: Mitchell R. Kamrava         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mitchell Kamrava UCLA / Jonsson Comprehensive Cancer Center

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02701153     History of Changes
Other Study ID Numbers: 15-001657
NCI-2016-00202 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Sarcoma Hypofractionated
15-001657 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms