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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04219202
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

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.

Condition or disease Intervention/treatment Phase
Sarcoma,Soft Tissue Radiation: Proton radiation Radiation: Carbon Ion radiation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : May 9, 2023
Estimated Study Completion Date : May 9, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Proton Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment
Radiation: Proton radiation
Therapeutic radiation Treatment with Protons

Experimental: Carbon Ion Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment
Radiation: Carbon Ion radiation
Therapeutic radiation Treatment with Carbon Ions




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. local Tumor control [ Time Frame: within 12 month after radiation treatment ]
    Number of patients without new arising Tumors at the treated Tumor site

  2. local Progression free survival [ Time Frame: within 12 month after radiation treatment ]
    Number of patients without local Progression at the treated tumor site

  3. disease free survival [ Time Frame: within 12 month after radiation treatment ]
    Number of Patients without relapse of treated disease

  4. Overall survival [ Time Frame: within 12 month after radiation treatment ]
    Assesment of alive patients

  5. Quality of live [ Time Frame: within 12 month after radiation treatment ]
    Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219202


Contacts
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Contact: Juergen Debus, Prof. +496221 ext 8201 juergen.debus@med.uni-heidelberg.de
Contact: Katharina Seidensaal, MD +496221 ext 8201 katharina.seidensaal@med.uni-heidelberg.de

Locations
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Germany
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Contact: Matthias Uhl, PD    +49-6221-56 ext 8202    Matthias.uhl@med.uni-heidelberg.de   
Contact: Adriane Hommertgen    +49-6221-56 ext 8202    adriane.hommertgen@med.uni-heidelberg.de   
Sub-Investigator: Katharina Seidensaal, MD         
Sponsors and Collaborators
University Hospital Heidelberg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juergen Debus, Princip Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04219202    
Other Study ID Numbers: Rad-ONK Retro-Ion
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms