Clinical trial NCT01811394: Ion Irradiation of Sacrococcygeal Chordoma
Official title: Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Sacral Chordoma
Keywords: sacral chordoma
chordoma
carbon ion therapy
proton therapy
hypofractionation
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique
timeFrame: From date of treatment start until 12 months after treatment.
Secondary outcomes:
measure: local progression free survival (LPFS)
timeFrame: From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.
measure: Overall survival (OS)
timeFrame: From date of treatment start until the date of death from any cause assessed up to 12 months.
measure: Quality of life (QoL)
timeFrame: From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment.
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Radiooncology, HIT
Study officials:
References:
citation: 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.