An interventional study of Randomized Cohort and Prospective cohort in Chordoma, sponsored by Italian Sarcoma Group. Recruiting at 28 sites in 10 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Italian Sarcoma Group · Not applicable, Interventional, and Treatment
Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma
International, multicenter, comparative, open-label, parallel-group, mixed Observational-Randomized Controlled Trial.
All the patients, who are candidate for the study will receive full information on the characteristics, potential effectiveness and side effects of the two alternatives treatments: radiotherapy (RT) and surgical treatment Eligible patients will be asked to be randomized in order to receive treatment A (surgery, with or without RT) or treatment B (definitive RT) Who will refuse randomization will be included in the Prospective Cohort Study (PCS) and will be treated accordingly to their choice (treatment option A or treatment option B).
The same radiotherapy and surgical regimen will be administered in the PCS and in the Randomized Clinical Trial (RCT) cohort
68 studies on the registry are indexed under Chordoma; 15 are open to participants now.
This study's planned enrollment of 100 is above the median of 38 across 50 interventional studies indexed under Chordoma.
Browse Chordoma studies →Italian Sarcoma Group is the lead sponsor of 31 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment
Other: Randomized Cohort
Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice
Radiation: Prospective cohort
Surgical treatment with different approach, based on the characteristics of the tumor or definitive high dose radiotherapy (carbon ion radiotherapy, proton-therapy, mixed photons-proton therapy) will be assigned by randomization
Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated
Relapse Free Survival (RFS)
The time from randomization or treatment start date to the date of local disease relapse, distant disease relapse, second primary malignancy or death from any cause, whichever occurred first.
Time frame: 5 years
Overall Survival (OS)
The time from randomization or treatment start date to the date of death from any cause
Time frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years)
Survival Post Progression (SPP)
The time from local disease relapse, distant disease relapse or second primary malignancy, whichever occurred first, to the date of death from any cause
Time frame: Expected average: 36 months
Local Relapse Failure (LRF)
The time from randomization or treatment start date to the date of local disease relapse
Time frame: Expected average: 60 months
Distant Relapse Failure (DRF)
The time from randomization or treatment start date to the date of distant disease relapse
Time frame: Expected average: 60 months
Best Response rate to definitive radiotherapy
Best Response rate to definitive radiotherapy
Time frame: At 12 months, 2 years and 5 years after radiotherapy
Time to best response rate to definitive radiotherapy
Time to best response rate to definitive radiotherapy
Time frame: At 12 months, 2 years and 5 years after radiotherapy
Adverse Events Incidence
Adverse Events incidence
Time frame: At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy
Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General
Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General
Time frame: every 6 months (expected average: 5 years)
Evaluation of quality of life measured with Brief Inventory Pain questionnaires
Evaluation of quality of life measured with Brief Inventory Pain questionnaires
Time frame: every 6 months (expected average: 5 years)
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Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Italian Sarcoma Group