Ion Irradiation of Sacrococcygeal Chordoma

Phase 2

Active, not recruiting

• Conditions: Sacral Chordoma
• Interventions: Radiation: protons; Radiation: carbon ions

• Registration Number: NCT01811394
• Lead Sponsor: Heidelberg University

Brief Summary

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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-09
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2023-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protons	protons	16x4GyE protons
Carbon ions	carbon ions	16x4GyE carbon ions

Primary Outcome Measures

Name	Time	Method
safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique	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

Secondary Outcome Measures

Name	Time	Method
local progression free survival (LPFS)	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)
Quality of life (QoL)	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.
Overall survival (OS)	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

Trial Locations

Locations (1)

University of Heidelberg, Radiooncology, HIT; 🇩🇪 Heidelberg, Germany