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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
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Medical University of Graz
Graz, Austria
RECRUITINGEBG GmbH MedAustron
Wiener Neustadt, Österreich, Austria
RECRUITINGMedical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
Dresden, Germany
NOT_YET_RECRUITINGUniversity Hospital Carl Gustav Carus Dresden
Dresden, Germany
NOT_YET_RECRUITINGUniversity Hospital Essen. West German Proton Therapy Center Essen
Essen, Germany
RECRUITINGHeidelberg Ion-Beam Therapy Center - HIT
Heidelberg, Germany
NOT_YET_RECRUITINGNational Center for Spinal Disorders
Budapest, Hungary
NOT_YET_RECRUITINGFondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy
RECRUITINGIstituto Ortopedico Rizzoli
Bologna, Italy
RECRUITINGAzienda Ospedaliero-Universitaria Careggi
Florence, Italy
NOT_YET_RECRUITING...and 18 more locations
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)