Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy

March 31, 2020 updated by: N.N. Petrov National Medical Research Center of Oncology

Combined treatment of soft tissue sarcoma includes 3 steps:

  1. step - preoperative stereotactic radiation therapy in hypofractionation mode
  2. step - operation
  3. step - postoperative conformal radiation therapy in normofractionation mode

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Combined treatment of soft tissue sarcoma includes 3 steps:

  1. 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.

  2. Second step is surgery in 14-21 days.
  3. 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation
        • Recruiting
        • National Research Center of Oncology named after N.N.Petrov
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SaE treatment

This group will receive combined treatment of soft tissue sarcoma that include 3 steps:

  1. step - preoperative stereotactic radiation therapy in hypofractionation mode (5 fractions 5 Gy each)
  2. step - operation
  3. step - postoperative conformal radiation therapy in normofractionation mode (25 fractions 2 Gy each)
Radiation: Preoperative stereotactic radiation therapy in hypofractionation mode

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.

Procedure: Surgery
In 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed
Radiation: Postoperative conformal radiation therapy in normofractionation mode

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 year
Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free survival
Time Frame: 3 year
Disease-Free survival will be evaluated after completing the protocol or during the protocol if local recurrence will appear.
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2028

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SaE in STS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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