Clinical Trial: Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
Brief Summary: Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma
Detailed Summary:
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
Sponsor: Italian Sarcoma Group
Current Primary Outcome: Relapse Free Survival (RFS) [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall Survival (OS) [ Time Frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years) ]The time from randomization or treatment start date to the date of death from any cause
- Survival Post Progression (SPP) [ Time Frame: Expected average: 36 months ]The time from local disease relapse, distant disease relapse or second primary malignancy, whichever occurred first, to the date of death from any cause
- Local Relapse Failure (LRF) [ Time Frame: Expected average: 60 months ]The time from randomization or treatment start date to the date of local disease relapse
- Distant Relapse Failure (DRF) [ Time Frame: Expected average: 60 months ]The time from randomization or treatment start date to the date of distant disease relapse
- Best Response rate to definitive radiotherapy [ Time Frame: At 12 months, 2 years and 5 years after radiotherapy ]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 ]Time to best response rate to definitive radiotherapy
- Adverse Events Incidence [ Time Frame: At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy ]Adverse Events incidence
- 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 Functional Assessment of Cancer Therapy General
- Evaluation of quality of life measured with Brief Inventory Pain questionnaires [ Time Frame: every 6 months (expected average: 5 years) ]Evaluation of quality of life measured with Brief Inventory Pain questionnaires
Original Secondary Outcome:
- Overall Survival (OS) [ Time Frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years) ]The time from randomization or treatment start date to the date of death from any cause
- Survival Post Progression (SPP) [ Time Frame: Expected average: 36 months ]The time from local disease relapse, distant disease relapse or second primary malignancy, whichever occurred first, to the date of death from any cause
- Local Relapse Failure (LRF) [ Time Frame: Expected average: 60 months ]The time from randomization or treatment start date to the date of local disease relapse
- Distant Relapse Failure (DRF) [ Time Frame: Expected average: 60 months ]The time from randomization or treatment start date to the date of distant disease relapse
- 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 Frame: At 12 months, 2 years and 5 years after radiotherapy ]
- 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 [ Time Frame: every 6 months (expected average: 5 years) ]
- Evaluation of quality of life measured with Brief Inventory Pain questionnaires [ Time Frame: every 6 months (expected average: 5 years) ]
Information By: Italian Sarcoma Group
Dates:
Date Received: December 2, 2016
Date Started: March 16, 2017
Date Completion: September 2022
Last Updated: March 16, 2017
Last Verified: March 2017