Suspended

ISACHypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma

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What is being tested

protons

+ carbon ions

Radiation
Who is being recruted

Neoplasms+1

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

From 18 to 80 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorHeidelberg University
Last updated: December 6, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection. The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity (CTCAE, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. Local-progression free survival, overall survival and quality of life will be analyzed as secondary end points.

NCT01811394
Principal SponsorHeidelberg University
Last updated: December 6, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalChordoma

Criteria

5 inclusion criteria required to participate
Histological confirmation of sacrococcygeal chordoma
Karnofsky performance status >= 70%
Macroscopic tumour (MRI)
Patients age 18 - 80 years
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7 exclusion criteria prevent from participating
Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)
Lack of macroscopic tumour
Metal implants at the level of the tumor which could influence the treatment planning
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
16x4GyE protons

Group II

Experimental
16x4GyE carbon ions

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Heidelberg, Radiooncology, HIT

Heidelberg, GermanyOpen University of Heidelberg, Radiooncology, HIT in Google Maps
SuspendedOne Study Center