Sarcoma,Soft Tissue Clinical Trial
— Retro-IonOfficial title:
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | May 9, 2027 |
Est. primary completion date | May 9, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable - Karnofsky index of = 70% - Age from 18 years - Completed patient information and written consent - ability to give consent Exclusion Criteria: - Stage IV (distant metastases) - Lymphogenic metastasis - Metal implants at the level of the sarcoma, which influence the treatment planning - Previous radiation therapy in the treatment area - Desmoid tumors, peritoneal sarcomatosis, GIST - Simultaneous participation in another clinical study that could influence the results of the respective study - Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator) - Pregnant women |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Heidelberg, Radiation Oncology | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of grad 3-5 NCI-CTC-AE toxicities | Evidence of the safety and practicability of the study treatment assessed for the incidence of grade 3-5 NCI-CTC-AE toxicity and / or termination of the planned therapy for any reason | within 12 month after radiation treatment | |
Secondary | local Tumor control | Number of patients without new arising Tumors at the treated Tumor site | within 12 month after radiation treatment | |
Secondary | local Progression free survival | Number of patients without local Progression at the treated tumor site | within 12 month after radiation treatment | |
Secondary | disease free survival | Number of Patients without relapse of treated disease | within 12 month after radiation treatment | |
Secondary | Overall survival | Assesment of alive patients | within 12 month after radiation treatment | |
Secondary | Quality of live | Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6 | within 12 month after radiation treatment |
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