Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID04330456

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

Led by N.N. Petrov National Medical Research Center of Oncology · Updated on 2020-04-01

30

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate a combined treatment approach for adults with soft tissue sarcoma. The treatment involves three key steps: preoperative stereotactic radiation therapy delivered in hypofractionation mode, followed by surgery, and then postoperative conformal radiation therapy given in normofractionation mode. The study focuses on carefully targeting the tumor and surrounding tissues based on MRI and CT scans to optimize treatment planning while protecting normal tissues. The first step includes preoperative stereotactic radiation therapy administered in 5 fractions, with specific doses targeted to the tumor and nearby tissues planned from fused MRI and CT imaging. Surgery is scheduled 14 to 21 days after this radiation. Then, 25 to 35 days following surgery, postoperative conformal radiation therapy is delivered in 25 fractions according to a standard protocol, with target areas defined based on tumor bed and surrounding zones. The treatment aims to limit radiation exposure to normal tissues that remain after surgery. Participants will undergo detailed imaging and treatment planning before radiation therapy. They will receive radiation in two stages around the surgery, which occurs between the two radiation phases. Researchers will monitor complications over three years as the primary outcome and assess disease-free survival as a secondary outcome. The total follow-up duration extends to at least three years to evaluate treatment safety and effectiveness.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Previous radiation treatment
  • Acute infection
  • Pregnancy or lactation
  • Recurrent tumor
  • Refusal to sign informed consent
  • Conditions that may affect treatment outcome (e.g., immunodeficiency, tuberculosis)
  • Tumor location or size not suitable for stereotactic and conformal radiation therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Preoperative Stereotactic Radiation Therapy

Duration - 5 treatment fractions

Participants receive preoperative stereotactic radiation therapy in hypofractionation mode, targeting the tumor and surrounding normal tissues planned for surgery.

5 visits for radiation therapy

Surgery and Immediate Post-operative Care

Duration - 1 day for surgery plus immediate recovery

Participants undergo radical surgery 14 to 21 days after completing preoperative radiation therapy.

1 visit for surgery

Postoperative Conformal Radiation Therapy

Duration - 25 treatment fractions

Participants receive postoperative conformal radiation therapy starting 25 to 35 days after surgery to the tumor bed and surrounding tissues according to standard protocols.

25 visits for radiation therapy

Trial Site Locations

Total: 1 location

1

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

Saint Petersburg, Russia

Actively Recruiting

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Research Team

G

Grigory Zinovev, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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