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

NCT04330456 | Recruiting

• 1 other identifier: SaE in STS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Combined treatment of soft tissue sarcoma includes 3 steps:

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

Conditions

Soft Tissue Sarcoma Adult

Outcome Measures

Primary Outcomes (1)

• Complications

  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 Outcomes (1)

• Disease-Free survival

  3 year

Study Arms (1)

SaE treatment

EXPERIMENTAL

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; Procedure: Surgery; Radiation: Postoperative conformal radiation therapy in normofractionation mode

Interventions

Preoperative stereotactic radiation therapy in hypofractionation mode RADIATION

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.

SaE treatment

Surgery PROCEDURE

In 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed

SaE treatment

Postoperative conformal radiation therapy in normofractionation mode RADIATION

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.

SaE treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

National Research Center of Oncology named after N.N.Petrov

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Grigory Zinovev, PhD

CONTACT

+79213405814; zinovevgrigory@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 1, 2020
• Study Start: February 1, 2020
• Primary Completion: July 1, 2022
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 1, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)