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 ]

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.


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