Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Incidence of grad 3-5 NCI-CTC-AE toxicities
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Proton Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment
Intervention: Proton radiation (Radiation)
Carbon Ion Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment
Intervention: Carbon Ion radiation (Radiation)
Outcomes
Primary Outcomes
Incidence of grad 3-5 NCI-CTC-AE toxicities
Time Frame: within 12 month after radiation treatment
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
Secondary Outcomes
- disease free survival(within 12 month after radiation treatment)
- Overall survival(within 12 month after radiation treatment)
- local Tumor control(within 12 month after radiation treatment)
- local Progression free survival(within 12 month after radiation treatment)
- Quality of live(within 12 month after radiation treatment)
Investigators
Juergen Debus
Princip Investigator
University Hospital Heidelberg