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Trial Title:
5-Day Preoperative Radiation for Soft Tissue Sarcoma
NCT ID:
NCT06087861
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
External Beam Radiotherapy
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
Arm group label:
External beam radiotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or
retroperitoneum.
2. Has been offered preoperative radiation and surgery as part of standard-of-care
treatment
3. Age ≥ 18
4. KPS ≥ 70 or ECOG 0 to 2
5. Life expectancy ≥ 6 months
6. If a woman is of childbearing potential, a negative serum or urine pregnancy test
must be documented.
7. Ability to understand and the willingness to personally sign the written IRB
approved informed consent document.
Exclusion Criteria:
1. History of prior radiation to the area to be treated.
2. Active use of other anti-cancer investigational agents.
3. 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).
4. Pregnancy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jillian Skerchak
Phone:
650-721-4072
Email:
jskerch1@stanford.edu
Investigator:
Last name:
Anusha Kalbasi, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Everett Moding
Email:
Sub-Investigator
Investigator:
Last name:
Susie Hiniker
Email:
Sub-Investigator
Start date:
October 6, 2023
Completion date:
January 2026
Lead sponsor:
Agency:
Stanford University
Agency class:
Other
Source:
Stanford University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06087861
