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Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)

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ClinicalTrials.gov Identifier: NCT02986516
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group

Brief Summary:
Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma

Condition or disease Intervention/treatment Phase
Chordoma Other: Randomized Cohort Radiation: Prospective cohort Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Randomized Cohort
Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment
Other: Randomized 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

Active Comparator: Prospective 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 or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Best Response rate to definitive radiotherapy [ Time Frame: At 12 months, 2 years and 5 years after radiotherapy ]
    Best Response rate to definitive radiotherapy

  6. 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

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Macroscopic tumor detectable at MRI/CT scan
  • Patient amenable for surgery
  • Patient amenable for RT
  • Written informed consent given before the enrolment, according to International Conference on Harmonisation/good clinical practice (ICH/GCP).

Exclusion Criteria:

  • Distant metastasis
  • Inability to maintain treatment position
  • Prior radiotherapy to the pelvic region
  • Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)
  • Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field)
  • Rectal wall infiltration
  • General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria)
  • Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia)
  • Severe comorbidities resulting in a prognosis of less than 6 months
  • Inability to give informed consent
  • Other malignancy within the last 5 years
  • Performance status ≥ 2 (ECOG).
  • Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
  • Significant systemic diseases grade >3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity
  • Women who are pregnant or breast-feeding
  • Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986516


Contacts
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Contact: Alessandro Gronchi, MD +390223903714 alessandro.gronchi@istitutotumori.mi.it
Contact: Emanuela Marchesi 003905101459 ext 78 emanuela.marchesi@italiansarconmagroup.org

Locations
Show Show 25 study locations
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
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Principal Investigator: Alessandro Gronchi, MD Istituto Nazionale Tumori Milan-Italy
Principal Investigator: Piero Fossati, MD MedAustron Graz-Austria
Publications:

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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT02986516    
Other Study ID Numbers: ISG SACRO
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms