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Ion Irradiation of Sacrococcygeal Chordoma (ISAC)

Primary Purpose

Sacral Chordoma

Status
Suspended
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
protons
carbon ions
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacral Chordoma focused on measuring sacral chordoma, chordoma, carbon ion therapy, proton therapy, hypofractionation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Heidelberg, Radiooncology, HIT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

protons

Carbon ions

Arm Description

16x4GyE protons

16x4GyE carbon ions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

local progression free survival (LPFS)
local progression free survival (LPFS) is determined from start of treatment until local progression in imaging (>10% size increase)
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
Quality of life (QoL)
Quality of life (QoL) evaluated with EORTC-QLQ30 questionnaire.

Full Information

First Posted
March 9, 2013
Last Updated
November 26, 2022
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01811394
Brief Title
Ion Irradiation of Sacrococcygeal Chordoma
Acronym
ISAC
Official Title
Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Toxicity evaluation
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacral Chordoma
Keywords
sacral chordoma, chordoma, carbon ion therapy, proton therapy, hypofractionation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
protons
Arm Type
Experimental
Arm Description
16x4GyE protons
Arm Title
Carbon ions
Arm Type
Experimental
Arm Description
16x4GyE carbon ions
Intervention Type
Radiation
Intervention Name(s)
protons
Intervention Description
Treatment is performed using 16 x 4 GyE protons
Intervention Type
Radiation
Intervention Name(s)
carbon ions
Intervention Description
Treatment is performed using 16 x 4 GyE carbon ions
Primary Outcome Measure Information:
Title
safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique
Description
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
Time Frame
From date of treatment start until 12 months after treatment.
Secondary Outcome Measure Information:
Title
local progression free survival (LPFS)
Description
local progression free survival (LPFS) is determined from start of treatment until local progression in imaging (>10% size increase)
Time Frame
From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.
Title
Overall survival (OS)
Description
Further objectives are overall survival (OS) from date of treatment start until the date of death from any cause assessed up to 12 months
Time Frame
From date of treatment start until the date of death from any cause assessed up to 12 months.
Title
Quality of life (QoL)
Description
Quality of life (QoL) evaluated with EORTC-QLQ30 questionnaire.
Time Frame
From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University of Heidelberg, Radiooncology, HIT
City
Heidelberg
ZIP/Postal Code
69125
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24774721
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.
Results Reference
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Ion Irradiation of Sacrococcygeal Chordoma

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