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出境医 / 临床实验 / Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Study Description
Brief Summary:

One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation.

Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.


Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Radiation: Hypofractionated Radiotherapy Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2026
Arms and Interventions
Arm Intervention/treatment
Experimental: Hypofractionated Radiotherapy for Soft Tissue Sarcoma
Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks.
 Radiation: Hypofractionated Radiotherapy
Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Outcome Measures
Primary Outcome Measures :
  1. Proportion of Participants with 2-year Local Control [ Time Frame: up to 2 years ]
    The primary endpoint is 2-year local control, defined as the proportion of participants whose best response as determined per RECIST criteria using imaging is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) out of all participants who have received at least one fraction. Local control will be reported with an exact 95% confidence interval (CI).


Secondary Outcome Measures :
  1. Proportion of Participants with 2-year Local Control: Primary Site vs Metastatic Site [ Time Frame: up to 2 years ]
    2-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.

  2. Proportion of Participants with 5-year Local Control: Primary Site vs Metastatic Site [ Time Frame: up to 5 years ]
    5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.

  3. Complete Response Rate [ Time Frame: up to 5 years ]
    The complete response (CR) rate will be reported with an exact 95% CI.

  4. Progression Free Survival [ Time Frame: up to 5 years ]
    Progression free survival (PFS) defined with follow-up radiological assessment with PFS calculated from the point of start of hypofractionated radiotherapy to the point of recurrence or death. Participants without documented progression who are alive at last follow-up will be censored at the date of the last radiologic assessment. PFS will be estimated using the Kaplan-Meier method.

  5. Overall Survival [ Time Frame: up to 5 years ]
    Overall survival (OS) defined from the point of start of hypofractionated radiotherapy to the time of death or last follow-up if alive. Participants who are alive at last follow-up will be censored. OS will be estimated using the Kaplan-Meier method.

  6. Incidence of Acute Toxicity [ Time Frame: up to 8 weeks ]
    Tabulated by type and grade.

  7. Incidence of Long Term Toxicity [ Time Frame: up to 5 years ]
    Tabulated by type and grade.


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:

  • Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy.
  • Participant refuses surgery or is aware that surgery is not recommended for them
  • Karnofsky performance status > 60
  • Able to understand and sign an informed consent form

Exclusion Criteria:

  • Pregnant
  • Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
  • Unable to undergo imaging or positioning necessary for radiotherapy planning
  • Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.
Contacts and Locations

Contacts
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Contact: Cancer Connect 608-263-8600 clinicaltrials@cancer.wisc.edu

Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Cancer Connect    608-263-8600    clinicaltrials@cancer.wisc.edu   
Principal Investigator: Zachary Morris, MD, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Zachary Morris, MD, PhD University of Wisconsin, Madison
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE June 11, 2019
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019) 		Proportion of Participants with 2-year Local Control [ Time Frame: up to 2 years ]
The primary endpoint is 2-year local control, defined as the proportion of participants whose best response as determined per RECIST criteria using imaging is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) out of all participants who have received at least one fraction. Local control will be reported with an exact 95% confidence interval (CI).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2020)
  • Proportion of Participants with 2-year Local Control: Primary Site vs Metastatic Site [ Time Frame: up to 2 years ]
    2-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.
  • Proportion of Participants with 5-year Local Control: Primary Site vs Metastatic Site [ Time Frame: up to 5 years ]
    5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.
  • Complete Response Rate [ Time Frame: up to 5 years ]
    The complete response (CR) rate will be reported with an exact 95% CI.
  • Progression Free Survival [ Time Frame: up to 5 years ]
    Progression free survival (PFS) defined with follow-up radiological assessment with PFS calculated from the point of start of hypofractionated radiotherapy to the point of recurrence or death. Participants without documented progression who are alive at last follow-up will be censored at the date of the last radiologic assessment. PFS will be estimated using the Kaplan-Meier method.
  • Overall Survival [ Time Frame: up to 5 years ]
    Overall survival (OS) defined from the point of start of hypofractionated radiotherapy to the time of death or last follow-up if alive. Participants who are alive at last follow-up will be censored. OS will be estimated using the Kaplan-Meier method.
  • Incidence of Acute Toxicity [ Time Frame: up to 8 weeks ]
    Tabulated by type and grade.
  • Incidence of Long Term Toxicity [ Time Frame: up to 5 years ]
    Tabulated by type and grade.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Proportion of Participants with 2-year Local Control: Primary Site vs Metastatic Site [ Time Frame: up to 2 years ]
    2-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.
  • Proportion of Participants with 5-year Local Control: Primary Site vs Metastatic Site [ Time Frame: up to 5 years ]
    5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.
  • Complete Response Rate [ Time Frame: up to 5 years ]
    The complete response (CR) rate will be reported with an exact 95% CI.
  • Progression Free Survival [ Time Frame: up to 5 years ]
    Progression free survival (PFS) defined with follow-up radiological assessment with PFS calculated from the point of start of SBRT to the point of recurrence or death. Participants without documented progression who are alive at last follow-up will be censored at the date of the last radiologic assessment. PFS will be estimated using the Kaplan-Meier method.
  • Overall Survival [ Time Frame: up to 5 years ]
    Overall survival (OS) defined from the point of start of SBRT to the time of death or last follow-up if alive. Participants who are alive at last follow-up will be censored. OS will be estimated using the Kaplan-Meier method.
  • Incidence of Acute Toxicity [ Time Frame: up to 8 weeks ]
    Tabulated by type and grade.
  • Incidence of Long Term Toxicity [ Time Frame: up to 5 years ]
    Tabulated by type and grade.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Radiotherapy for Soft Tissue Sarcomas
Official Title  ICMJE Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas
Brief Summary

One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation.

Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Soft Tissue Sarcoma
Intervention  ICMJE Radiation: Hypofractionated Radiotherapy
Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Study Arms  ICMJE Experimental: Hypofractionated Radiotherapy for Soft Tissue Sarcoma
Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks.
Intervention: Radiation: Hypofractionated Radiotherapy
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: May 31, 2019) 		48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2026
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy.
  • Participant refuses surgery or is aware that surgery is not recommended for them
  • Karnofsky performance status > 60
  • Able to understand and sign an informed consent form

Exclusion Criteria:

  • Pregnant
  • Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
  • Unable to undergo imaging or positioning necessary for radiotherapy planning
  • Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.
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: Cancer Connect 608-263-8600 clinicaltrials@cancer.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972930
Other Study ID Numbers  ICMJE UW18149
2019-0360 ( Other Identifier: Institutional Review Board )
A533300 ( Other Identifier: UW Madison )
SMPH/HUMAN ONCOLOGY/HUMAN ONCO ( Other Identifier: UW Madison )
NCI-2019-03768 ( Registry Identifier: NCI Trial ID )
Protocol Version 2/4/2020 ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zachary Morris, MD, PhD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date March 2021

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

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