Ion Irradiation of Sacrococcygeal Chordoma (ISAC)

Heidelberg University

Status and phase

Active, not recruiting

Phase 2

Conditions

Sacral Chordoma

Treatments

Radiation: carbon ions

Radiation: protons

Study type

Interventional

Funder types

Other

Identifiers

NCT01811394

ISAC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)