NCT04219202

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
May 2019May 2027

Study Start

First participant enrolled

May 9, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

7 years

First QC Date

January 3, 2020

Last Update Submit

March 6, 2026

Conditions

Sarcoma,Soft Tissue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • local Tumor control

    within 12 month after radiation treatment

  • local Progression free survival

    within 12 month after radiation treatment

  • disease free survival

    within 12 month after radiation treatment

  • Overall survival

    within 12 month after radiation treatment

  • Quality of live

    within 12 month after radiation treatment

Study Arms (2)

Proton Treatment

ACTIVE COMPARATOR

Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment

Radiation: Proton radiation

Carbon Ion Treatment

EXPERIMENTAL

Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment

Radiation: Carbon Ion radiation

Interventions

Proton radiationRADIATION

Therapeutic radiation Treatment with Protons

Proton Treatment
Carbon Ion radiationRADIATION

Therapeutic radiation Treatment with Carbon Ions

Carbon Ion Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

  • 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: 33579340DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Proton TherapyHeavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Central Study Contacts

Juergen Debus, Prof.

CONTACT

+496221juergen.debus@med.uni-heidelberg.de

Katharina Kozyra, Dr

CONTACT

+496221katharina.kozyra@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Princip Investigator

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 6, 2020

Study Start

May 9, 2019

Primary Completion (Estimated)

May 9, 2026

Study Completion (Estimated)

May 9, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)