Ion Irradiation of Sacrococcygeal Chordoma (ISAC)

November 29, 2023 updated by: Klaus Herfarth, MD, Heidelberg University

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

The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the raster scan technique.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69125
        • University of Heidelberg, Radiooncology, HIT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological confirmation of sacrococcygeal chordoma
  • Karnofsky performance status ≥ 70%
  • Patients age 18 - 80 years
  • Macroscopic tumour (MRI)
  • Written informed consent

Exclusion Criteria:

  • Lack of macroscopic tumour
  • Tumor extension in craniocaudal direction >16cm
  • Metal implants at the level of the tumor which could influence the treatment planning
  • Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)
  • Prior radiotherapy of the pelvic region
  • Simultaneous participation in another trial that could influence the results of the study
  • Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: protons
16x4GyE protons
Radiation: protons
Treatment is performed using 16 x 4 GyE protons
Experimental: Carbon ions
16x4GyE carbon ions
Radiation: carbon ions
Treatment is performed using 16 x 4 GyE carbon ions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique
Time Frame: From date of treatment start until 12 months after treatment.
The evaluation is based on incidence of Grade 3-5 toxicity (NCI-CTC-AE) and/or discontinuation of the treatment for any reason. Endpoint is the proportion of treatments without Grade 3-5 toxicity (NCI-CTC-AE) up to 12 months after treatment and/or discontinuation of the treatment for any reason
From date of treatment start until 12 months after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local progression free survival (LPFS)
Time Frame: From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.
local progression free survival (LPFS) is determined from start of treatment until local progression in imaging (>10% size increase)
From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.
Overall survival (OS)
Time Frame: From date of treatment start until the date of death from any cause assessed up to 12 months.
Further objectives are overall survival (OS) from date of treatment start until the date of death from any cause assessed up to 12 months
From date of treatment start until the date of death from any cause assessed up to 12 months.
Quality of life (QoL)
Time Frame: From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment.
Quality of life (QoL) evaluated with EORTC-QLQ30 questionnaire.
From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

February 1, 2023

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 9, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimated)

March 14, 2013

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISAC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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