RecruitingNot ApplicableNCT04330456

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


Sponsor

N.N. Petrov National Medical Research Center of Oncology

Enrollment

30 participants

Start Date

Feb 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combined radiation approach for people with soft tissue sarcoma (a cancer that forms in muscles, tendons, fat, or other connective tissues). The approach involves giving a focused, high-dose radiation treatment before surgery, followed by a more standard radiation treatment after surgery — to try to improve outcomes while minimizing damage to surrounding healthy tissue. **You may be eligible if...** - You have been newly diagnosed with soft tissue sarcoma (confirmed by biopsy) - Your tumor has not been treated before (no prior radiation or surgery for this cancer) - Surgery to fully remove your tumor is planned and appears possible - Radiation therapy is recommended as part of your treatment - You have no medical reasons preventing radiation or surgery **You may NOT be eligible if...** - You have had prior radiation treatment - You have an active infection - You are pregnant or breastfeeding - Your tumor has come back after prior treatment - Your tumor's size or location makes the planned radiation techniques impossible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPreoperative 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.

PROCEDURESurgery

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

RADIATIONPostoperative 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.


Locations(1)

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

Saint Petersburg, Russia

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NCT04330456


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