Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease
ConditionChordoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorItalian Sarcoma Group
About this trial
Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx.
Age≥18years
ECOG-performance status (PS) 0-2
No previous antineoplastic therapy
Disqualifiers
Distant metastasis
Inability to maintain treatment position
Prior radiotherapy to the pelvic region
Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)
Trial design
Design model
Parallel
Treatments tested in this trial
Randomized Cohort
Other interventionSurgical 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
Prospective cohort
RadiationSurgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Randomized CohortExperimental treatment 1 intervention
Group B: Prospective CohortActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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)2
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 months3
Local Relapse Failure (LRF)
The time from randomization or treatment start date to the date of local disease relapse
Time frame
Expected average: 60 months4
Distant Relapse Failure (DRF)
The time from randomization or treatment start date to the date of distant disease relapse
Time frame
Expected average: 60 monthsSponsors and contacts
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Source ClinicalTrials.gov