RecruitingNot ApplicableNCT04219202

Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion

Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie

Sponsor

University Hospital Heidelberg

Enrollment

64 participants

Start Date

May 9, 2019

Study Type

INTERVENTIONAL

Conditions

Sarcoma,Soft Tissue

Summary

The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and / or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving radiation therapy before surgery (neoadjuvant irradiation) for retroperitoneal soft tissue sarcomas (rare cancers in the back of the abdomen) can improve the chance of removing all the cancer and reducing local recurrence. **You may be eligible if...** - You have retroperitoneal soft tissue sarcoma confirmed by biopsy that can potentially be removed by surgery - You are 18 or older - Your general health is adequate (Karnofsky index at or above 70%) - You can provide informed consent **You may NOT be eligible if...** - Your cancer has spread to distant organs (stage IV) - Your cancer has spread to lymph nodes - You have metal implants near the sarcoma that would interfere with radiation planning - You have had prior radiation to the same area - Your tumor is a desmoid tumor, GIST, or peritoneal sarcomatosis - You have a pacemaker or active implant not cleared for ion radiation - You are pregnant 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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