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Recruiting NCT04219202

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

No phase Interventional Sarcoma,Soft Tissue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proton radiation, Carbon Ion radiation.
Who it may be relevant to
Registry conditions: Sarcoma,Soft Tissue. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Proton radiation
    Therapeutic radiation Treatment with Protons
  • Radiation Carbon Ion radiation
    Therapeutic radiation Treatment with Carbon Ions

Primary outcome measures

  • Incidence of grad 3-5 NCI-CTC-AE toxicities [Time frame: within 12 month after radiation treatment]
Secondary outcome measures (5)
  • local Tumor control [Time frame: within 12 month after radiation treatment]
  • local Progression free survival [Time frame: within 12 month after radiation treatment]
  • disease free survival [Time frame: within 12 month after radiation treatment]
  • Overall survival [Time frame: within 12 month after radiation treatment]
  • Quality of live [Time frame: within 12 month after radiation treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Hospital of Heidelberg, Radiation Oncology — Heidelberg

Publications

  • Seidensaal K, Kieser M, Hommertgen A, Jaekel C, Harrabi SB, Herfarth K, Mechtesheimer G, Lehner B, Schneider M, Nienhueser H, Frohling S, Egerer G, Debus J, Uhl M. Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial. Trials. 2021 Feb 12;22(1):134. doi: 10.1186/s13063-021-05069-z. PMID 33579340

Identifiers

NCT: NCT04219202 · Rad-ONK Retro-Ion

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗