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Ion Irradiation of Sacrococcygeal Chordoma

NCT ID: NCT01811394

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Sacral Chordoma

Keywords

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sacral chordoma chordoma carbon ion therapy proton therapy hypofractionation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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protons

16x4GyE protons

Group Type EXPERIMENTAL

protons

Intervention Type RADIATION

Treatment is performed using 16 x 4 GyE protons

Carbon ions

16x4GyE carbon ions

Group Type EXPERIMENTAL

carbon ions

Intervention Type RADIATION

Treatment is performed using 16 x 4 GyE carbon ions

Interventions

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protons

Treatment is performed using 16 x 4 GyE protons

Intervention Type RADIATION

carbon ions

Treatment is performed using 16 x 4 GyE carbon ions

Intervention Type RADIATION

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Klaus Herfarth, MD

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Heidelberg, Radiooncology, HIT

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 24774721 (View on PubMed)

Other Identifiers

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ISAC-01

Identifier Type: -

Identifier Source: org_study_id