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

This study is currently recruiting participants.
Verified September 2017 by Italian Sarcoma Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT02986516
First Posted: December 8, 2016
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Italian Sarcoma Group
  Purpose
Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma

Condition Intervention
Chordoma Other: Randomized Cohort Radiation: Prospective cohort

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Italian Sarcoma Group:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 100
Actual Study Start Date: March 16, 2017
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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
Contact: Alessandro Gronchi, MD +390223903714 alessandro.gronchi@istitutotumori.mi.it

Locations
Austria
Medical University of Graz Not yet recruiting
Graz, Austria
Contact: Andreas Leithner, MD         
Principal Investigator: Andreas Leithner, MD         
Germany
University Hospital Carl Gustav Carus Dresden Not yet recruiting
Dresden, Germany
Contact: Mechthild Krause, MD         
Principal Investigator: Mechthild Krause, MD         
the University Hospital Essen. West German Proton Therapy Center Essen Not yet recruiting
Essen, Germany
Contact: Beate Timmermann, MD         
Principal Investigator: Beate Timmermann, MD         
Heidelberg Ion-Beam Therapy Center - HIT Not yet recruiting
Heidelberg, Germany
Contact: Matthias Uhl, MD         
Principal Investigator: Matthias Uhl, MD         
Hungary
National Center for Spinal Disorders Not yet recruiting
Budapest, Hungary
Contact: Peter P Varga, MD         
Principal Investigator: Peter P Varga, MD         
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, MI, Italy, 20133
Contact: Alessandro Gronchi, MD       alessandro.gronchi@istitutotumori.mi.it   
Principal Investigator: Alessandro Gronchi, MD         
Istituto Ortopedico Rizzoli Active, not recruiting
Bologna, Italy, 40136
Azienda Ospedaliero-Universitaria Careggi Not yet recruiting
Firenze, Italy, 50134
Contact: Domenico A Campanacci, MD         
Principal Investigator: Domenico A Campanacci, MD         
Istituto Clinico Humanitas Active, not recruiting
Milano, Italy, 20089
I.R.C.C.S. Istituto Ortopedico Galeazzi Not yet recruiting
Milano, Italy, 20161
Contact: Alessandro Luzzati, MD       alessandro.luzzati@grupposandonato.it   
Principal Investigator: Alessandro Luzzati, MD         
Centro Nazionale di Adroterapia Oncologica - CNAO Recruiting
Pavia, Italy, 27100
Contact: Piero Fossati, MD       Piero.Fossati@Cnao.it   
Principal Investigator: Piero Fossati, MD         
II Clinica Universitaria Ortopedia e Traumatologia AO Pisa Not yet recruiting
Pisa, Italy, 56124
Contact: Rodolfo Capanna, MD         
Principal Investigator: Rodolfo Capanna, MD         
Istituto Regina Elena - IFO Active, not recruiting
Rome, Italy, 00100
Agenzia Provinciale per la Protonterapia - AtreP Active, not recruiting
Trento, Italy, 38122
Japan
Saitama Medical Center Not yet recruiting
Saitama, Japan
Contact: Toru Akiyama, MD         
Principal Investigator: Toru Akiyama, MD         
Netherlands
Netherlands Cancer Institute Not yet recruiting
Amsterdam, Netherlands
Contact: R LM Haas, MD         
Principal Investigator: R LM Haas, MD         
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Contact: Sander Dijkstra, MD         
Principal Investigator: Sander Dijkstra, MD         
Spain
Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain
Contact: Nadia Hindi, MD         
Principal Investigator: Nadia Hindi, MD         
United Kingdom
The Royal Orthopaedic Hospital Not yet recruiting
Birmingham, United Kingdom
Contact: Lee Jeys, MD         
Principal Investigator: Lee Jeys, MD         
Royal National Orthopaedic Hospital Not yet recruiting
London, United Kingdom
Contact: Rob Pollock, MD         
Principal Investigator: Rob Pollock, MD         
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
Principal Investigator: Alessandro Gronchi, MD Istituto Nazionale Tumori
Principal Investigator: Piero Fossati, MD Fondazione CNAO
  More Information

Publications:

Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT02986516     History of Changes
Other Study ID Numbers: ISG SACRO
First Submitted: December 2, 2016
First Posted: December 8, 2016
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms