Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04219202
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2020-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
Sponsor:
University Hospital Heidelberg
Organization:
Study Overview
Official Title:
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Retro-Ion
Brief 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.
Detailed Description:
With retroperitoneal sarcomas, the patient benefits from neoadjuvant radiotherapy. Due to the special physical properties of particles (protons and C12 carbon ions), in particular the steep lateral dose drop, an improved protection of adjacent risk organs is e.g. Intestine, kidneys, liver etc. during the process of applying radiotherapy is possible.
The primary study objective is to demonstrate the safety and conduct of study treatment and the incidence of Grade 3-5 NCI-CTC-AE toxicity and / or termination of preferred therapy for any reason. Further target parameter is the proportion of applied therapies without the occurance of degree 3-5 NCI-CTC-AE(s).
The patients are randomized 1: 1 into the two arms (carbon ions vs. protons). Patients receive 39 Gy in (SD 3.0 Gy) in 6 fractions per week.
Secondary study objectives are local control (LC), local progression-free survival from the start of therapy (LPFS), disease-free survival (DFS), overall survival (OS) and quality of life (QoL) determined according to the EORTC-Quality of Life Questionaire (QLQ)- C30 questionnaire.
The primary study objective is to demonstrate the safety and conduct of study treatment and the incidence of Grade 3-5 NCI-CTC-AE toxicity and / or termination of preferred therapy for any reason. Further target parameter is the proportion of applied therapies without the occurance of degree 3-5 NCI-CTC-AE(s).
The patients are randomized 1: 1 into the two arms (carbon ions vs. protons). Patients receive 39 Gy in (SD 3.0 Gy) in 6 fractions per week.
Secondary study objectives are local control (LC), local progression-free survival from the start of therapy (LPFS), disease-free survival (DFS), overall survival (OS) and quality of life (QoL) determined according to the EORTC-Quality of Life Questionaire (QLQ)- C30 questionnaire.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: