Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
Primary Purpose
Soft Tissue Sarcoma Adult
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Preoperative stereotactic radiation therapy in hypofractionation mode
Surgery
Postoperative conformal radiation therapy in normofractionation mode
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma Adult
Eligibility Criteria
Inclusion Criteria:
- morphologically verified diagnosis of soft tissue sarcoma
- first diagnosed tumor process
- ability to perform radical surgery
- signed informed consent
- indications for stereotactic and conformal radiation therapy
- no contraindications for radiation and surgical treatment
Exclusion Criteria:
- previous radiation treatment
- acute infection
- pregnancy, lactation
- recurrent tumor
- refuse to sign informed consent
- conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.)
- tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy.
Sites / Locations
- National Research Center of Oncology named after N.N.PetrovRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SaE treatment
Arm Description
This group will receive combined treatment of soft tissue sarcoma that include 3 steps: step - preoperative stereotactic radiation therapy in hypofractionation mode (5 fractions 5 Gy each) step - operation step - postoperative conformal radiation therapy in normofractionation mode (25 fractions 2 Gy each)
Outcomes
Primary Outcome Measures
Complications
Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy
Secondary Outcome Measures
Disease-Free survival
Disease-Free survival will be evaluated after completing the protocol or during the protocol if local recurrence will appear.
Full Information
NCT ID
NCT04330456
First Posted
March 26, 2020
Last Updated
March 31, 2020
Sponsor
N.N. Petrov National Medical Research Center of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT04330456
Brief Title
Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
Official Title
Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.N. Petrov National Medical Research Center of Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Combined treatment of soft tissue sarcoma includes 3 steps:
step - preoperative stereotactic radiation therapy in hypofractionation mode
step - operation
step - postoperative conformal radiation therapy in normofractionation mode
Detailed Description
Combined treatment of soft tissue sarcoma includes 3 steps:
At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues.
At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation.
GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.
Second step is surgery in 14-21 days.
In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.
PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SaE treatment
Arm Type
Experimental
Arm Description
This group will receive combined treatment of soft tissue sarcoma that include 3 steps:
step - preoperative stereotactic radiation therapy in hypofractionation mode (5 fractions 5 Gy each)
step - operation
step - postoperative conformal radiation therapy in normofractionation mode (25 fractions 2 Gy each)
Intervention Type
Radiation
Intervention Name(s)
Preoperative stereotactic radiation therapy in hypofractionation mode
Intervention Description
At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues.
At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation.
GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
In 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed
Intervention Type
Radiation
Intervention Name(s)
Postoperative conformal radiation therapy in normofractionation mode
Intervention Description
In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.
PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.
Primary Outcome Measure Information:
Title
Complications
Description
Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Disease-Free survival
Description
Disease-Free survival will be evaluated after completing the protocol or during the protocol if local recurrence will appear.
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
morphologically verified diagnosis of soft tissue sarcoma
first diagnosed tumor process
ability to perform radical surgery
signed informed consent
indications for stereotactic and conformal radiation therapy
no contraindications for radiation and surgical treatment
Exclusion Criteria:
previous radiation treatment
acute infection
pregnancy, lactation
recurrent tumor
refuse to sign informed consent
conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.)
tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grigory Zinovev, PhD
Phone
+79213405814
Email
zinovevgrigory@gmail.com
Facility Information:
Facility Name
National Research Center of Oncology named after N.N.Petrov
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grigory Zinovev, PhD
Phone
+79213405814
Email
zinovevgrigory@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
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