Clincosm LogoSign in Get a demo

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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02701153
Collaborator
Radiological Society of North America (Other), Sarcoma Alliance for Research through Collaboration (Other), Sarcoma Foundation of America (Other), Tower Cancer Research Foundation (Other)
51
Enrollment
1
Location
1
Arm
96
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Conventional Surgery
  • Radiation: Hypofractionated Radiation Therapy
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJCETIVES:
  1. Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.
SECONDARY OBJECTIVES:

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

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

  3. 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.

  4. 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

Study Type:
Interventional
Anticipated 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 :
Feb 3, 2016
Anticipated Primary Completion Date :
Feb 3, 2023
Anticipated Study Completion Date :
Feb 3, 2024

Arms and Interventions

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

    Primary Outcome Measures

    1. Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) [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 [Up to 3 years]

      Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.

    2. Local failure [Up to 3 years]

      Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used.

    3. Overall survival [Up to 3 years]

      Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.

    4. Progression free survival [Up to 3 years]

      Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.

    5. Regional failure [Up to 3 years]

      Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    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

    • Principal Investigator: Anusa Kalbasi, MD, UCLA / Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02701153
    Other Study ID Numbers:
    • 15-001657
    • NCI-2016-00202
    • 15-001657
    First Posted:
    Mar 8, 2016
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Mar 4, 2022