Ion Irradiation of Sacrococcygeal Chordoma

Sacral Chordoma Clinical Trial

— ISAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01811394
• Other study ID #: ISAC-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chordoma
• Sacral Chordoma

Intervention

Radiation:
• protons
Treatment is performed using 16 x 4 GyE protons
• carbon ions
Treatment is performed using 16 x 4 GyE carbon ions

Locations

Country	Name	City	State
Germany	University of Heidelberg, Radiooncology, HIT	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Uhl M, Edler L, Jensen AD, Habl G, Oelmann J, Roder F, Jackel O, Debus J, Herfarth K. Randomized phase II trial of hypofractionated proton versus carbon ion radiation therapy in patients with sacrococcygeal chordoma-the ISAC trial protocol. Radiat Oncol. 2014 Apr 29;9:100. doi: 10.1186/1748-717X-9-100. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique	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	local progression free survival (LPFS)	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.
Secondary	Overall survival (OS)	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.
Secondary	Quality of life (QoL)	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.