Back to results5-Day Preoperative Radiation for Soft Tissue Sarcoma
Primary Purpose
Soft Tissue Sarcoma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
External Beam Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum. Has been offered preoperative radiation and surgery as part of standard-of-care treatment Age ≥ 18 KPS ≥ 70 or ECOG 0 to 2 Life expectancy ≥ 6 months If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented. Ability to understand and the willingness to personally sign the written IRB approved informed consent document. Exclusion Criteria: History of prior radiation to the area to be treated. Active use of other anti-cancer investigational agents. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery). Pregnancy.
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
External beam radiotherapy
Arm Description
Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.
Outcomes
Primary Outcome Measures
Post-operative Complication Rate
Rate of post-operative complications.
Secondary Outcome Measures
Local Recurrence Rate
Rate of local recurrence, including in-field, borderline and out-field recurrences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06087861
Brief Title
5-Day Preoperative Radiation for Soft Tissue Sarcoma
Official Title
Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
External beam radiotherapy
Arm Type
Experimental
Arm Description
Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiotherapy
Intervention Description
Radiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day
Primary Outcome Measure Information:
Title
Post-operative Complication Rate
Description
Rate of post-operative complications.
Time Frame
120 days after surgery
Secondary Outcome Measure Information:
Title
Local Recurrence Rate
Description
Rate of local recurrence, including in-field, borderline and out-field recurrences
Time Frame
2 years and 5 years after surgical resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
Has been offered preoperative radiation and surgery as part of standard-of-care treatment
Age ≥ 18
KPS ≥ 70 or ECOG 0 to 2
Life expectancy ≥ 6 months
If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.
Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
Exclusion Criteria:
History of prior radiation to the area to be treated.
Active use of other anti-cancer investigational agents.
Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahjabin Noroozi
Phone
(650) 721-4069
Email
mnoroozi@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Wong
Phone
650-498-8495
Email
swong8@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anusha Kalbasi, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Wong
Phone
650-498-8495
Email
swong8@stanford.edu
First Name & Middle Initial & Last Name & Degree
Anusha Kalbasi, M.D.
First Name & Middle Initial & Last Name & Degree
Everett Moding
First Name & Middle Initial & Last Name & Degree
Susie Hiniker
12. IPD Sharing Statement
Learn more about this trial
5-Day Preoperative Radiation for Soft Tissue Sarcoma
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