Sacral ChordomaPhase 2ISACNCT01811394
Ion Irradiation of Sacrococcygeal Chordoma
A Phase 2 study testing protons and carbon ions in people with Sacral Chordoma, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sacral Chordoma
- What is being tested?
- protons and carbon ions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of sacrococcygeal chordoma
- Karnofsky performance status ≥ 70%
- Patients age 18 - 80 years
- Macroscopic tumour (MRI)
- Written informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma
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.
Read the 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.
- Conditions
- Sacral Chordoma
- Being tested
- protons, carbon ions
- Keywords
- sacral chordoma, chordoma, carbon ion therapy, proton therapy, hypofractionation
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protonsRadiation
Treatment is performed using 16 x 4 GyE protons
carbon ionsRadiation
Treatment is performed using 16 x 4 GyE carbon ions
| Study group | Role | What they receive |
|---|---|---|
| protons | Experimental | 16x4GyE protons Receives: Radiation: protons |
| Carbon ions | Experimental | 16x4GyE carbon ions Receives: Radiation: carbon ions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From date of treatment start until 12 months after treatment.
Secondary outcomes (3)
local progression free survival (LPFS)
local progression free survival (LPFS) is determined from start of treatment until local progression in imaging (>10% size increase)
Measured: From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.
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
Measured: 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.
Measured: From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2023
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacral ChordomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Herfarth, MD, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811394
- Sponsor's protocol ID
- ISAC-01
- Acronym
- ISAC
- Status last verified
- Nov 2023
- First submitted
- 9 Mar 2013
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24774721
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma
- ClinicalTrials.gov ID
- NCT01811394
- Acronym / sponsor ID
- ISAC / ISAC-01
- Conditions
- Sacral Chordoma
- Keywords
- sacral chordoma, chordoma, carbon ion therapy, proton therapy, hypofractionation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Feb 2023 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protons | Experimental | Radiation: protons16x4GyE protons |
| Carbon ions | Experimental | Radiation: carbon ions16x4GyE carbon ions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological confirmation of sacrococcygeal chordoma
- Karnofsky performance status ≥ 70%
- Patients age 18 - 80 years
- Macroscopic tumour (MRI)
- Written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protonsTreatment is performed using 16 x 4 GyE protons | Radiation | protons |
| carbon ionsTreatment is performed using 16 x 4 GyE carbon ions | Radiation | Carbon ions |
Primary outcome
safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique
Time frame: From date of treatment start until 12 months after treatment.
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
3 secondary outcomes
local progression free survival (LPFS)
Time frame: From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.
Overall survival (OS)
Time frame: From date of treatment start until the date of death from any cause assessed up to 12 months.
Quality of life (QoL)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 24774721Uhl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing protons and carbon ions in people with Sacral Chordoma, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique (time frame: From date of treatment start until 12 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01811394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.