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

September 12, 2023 updated by: Italian Sarcoma Group

Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University of Graz
        • Contact:
          • Andreas Leithner, MD
        • Principal Investigator:
          • Andreas Leithner, MD
    • Österreich
      • Wiener Neustadt, Österreich, Austria, 2700
  • Germany
      • Dresden, Germany
        • Not yet recruiting
        • Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
        • Contact:
          • Mechthild Krause, Prof/MD
        • Principal Investigator:
          • Mechthild Krause, Prof/MD
      • Dresden, Germany
        • Not yet recruiting
        • University Hospital Carl Gustav Carus Dresden
        • Contact:
          • Mechthild Krause, MD
        • Principal Investigator:
          • Mechthild Krause, MD
      • Essen, Germany
        • Recruiting
        • University Hospital Essen. West German Proton Therapy Center Essen
        • Contact:
          • Beate Timmermann, MD
        • Principal Investigator:
          • Beate Timmermann, MD
      • Heidelberg, Germany
        • Not yet recruiting
        • Heidelberg Ion-Beam Therapy Center - HIT
        • Contact:
          • Matthias Uhl, MD
        • Principal Investigator:
          • Matthias Uhl, MD
  • Hungary
      • Budapest, Hungary
        • Not yet recruiting
        • National Center for Spinal Disorders
        • Contact:
          • Peter P Varga, MD
        • Principal Investigator:
          • Peter P Varga, MD
  • Italy
      • Bologna, Italy, 40136
        • Recruiting
        • Istituto Ortopedico Rizzoli
        • Contact:
        • Principal Investigator:
          • Alessandro Gasbarrini, MD
      • Firenze, Italy, 50134
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Careggi
        • Contact:
          • Domenico A Campanacci, MD
        • Principal Investigator:
          • Domenico A Campanacci, MD
      • Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
        • Principal Investigator:
          • Ferdinando Cananzi, MD
      • Milano, Italy, 20161
        • Active, not recruiting
        • I.R.C.C.S. Istituto Ortopedico Galeazzi
      • Pavia, Italy, 27100
        • Recruiting
        • Centro Nazionale di Adroterapia Oncologica - CNAO
        • Contact:
        • Principal Investigator:
          • Maria Rosaria Fiore, MD
      • Pisa, Italy, 56124
        • Recruiting
        • II Clinica Universitaria Ortopedia e Traumatologia AO Pisa
        • Contact:
        • Principal Investigator:
          • Lorenzo Andreani, MD
      • Rome, Italy, 00100
        • Recruiting
        • Istituto Regina Elena - IFO
        • Contact:
        • Principal Investigator:
          • Maria Grazia Petrongari, MD
      • Trento, Italy, 38122
        • Active, not recruiting
        • Agenzia Provinciale per la Protonterapia - AtreP
    • MI
      • Milano, MI, Italy, 20133
  • Japan
      • Saitama, Japan
        • Recruiting
        • Saitama Medical Center
        • Contact:
          • Toru Akiyama, MD
        • Principal Investigator:
          • Toru Akiyama, MD
  • Netherlands
      • Amsterdam, Netherlands
        • Not yet recruiting
        • Netherlands Cancer Institute
        • Contact:
          • R LM Haas, MD
        • Principal Investigator:
          • R LM Haas, MD
      • Leiden, Netherlands
        • Not yet recruiting
        • Leiden University Medical Center
        • Contact:
          • Sander Dijkstra, MD
        • Principal Investigator:
          • Sander Dijkstra, MD
  • Norway
      • Oslo, Norway, N-0424
        • Recruiting
        • Norwegian Radium Hospital/Oslo Univeristi Hospital
        • Contact:
          • Øyvind S. Bruland, MD
          • Phone Number: 67 +47 22 93 47
          • Email: osb@ous-hf.no
        • Contact:
          • Øyvind S. Bruland, MD
  • Poland
      • Warsaw, Poland
        • Active, not recruiting
        • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
  • Spain
      • Barcelona, Spain
        • Recruiting
        • H. Val D'Hebron
        • Contact:
          • Ramona V. Capdevila, MD
        • Principal Investigator:
          • Ramona V. Capdevila, MD
      • Barcelona, Spain
        • Active, not recruiting
        • Hosptial San Pau
      • Madrid, Spain
        • Not yet recruiting
        • H. San Carlos
        • Contact:
          • Gloria M. Ospina, MD
        • Principal Investigator:
          • Gloria M. Ospina
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
          • Nadia Hindi, MD
        • Principal Investigator:
          • Nadia Hindi, MD
      • Valencia, Spain, 46017
        • Not yet recruiting
        • Hospital Universitario Doctor Peset
        • Contact:
        • Principal Investigator:
          • Antonio M. Benlloch, MD
  • United Kingdom
      • Birmingham, United Kingdom
        • Not yet recruiting
        • The Royal Orthopaedic Hospital
        • Contact:
          • Lee Jeys, MD
        • Principal Investigator:
          • Lee Jeys, MD
      • London, United Kingdom
        • Not yet recruiting
        • Royal National Orthopaedic Hospital
        • Contact:
          • Rob Pollock, MD
        • Principal Investigator:
          • Rob Pollock, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years)
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
Expected average: 36 months
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
Expected average: 60 months
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
Expected average: 60 months
Best Response rate to definitive radiotherapy
Time Frame: At 12 months, 2 years and 5 years after radiotherapy
Best Response rate to definitive radiotherapy
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
Time to best response rate to definitive radiotherapy
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
Adverse Events incidence
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 Functional Assessment of Cancer Therapy General
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)
Evaluation of quality of life measured with Brief Inventory Pain questionnaires
every 6 months (expected average: 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Investigators

  • Principal Investigator: Alessandro Gronchi, MD, Istituto Nazionale Tumori Milan-Italy
  • Principal Investigator: Piero Fossati, MD, MedAustron Graz-Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2017

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimated)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISG SACRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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