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

NCT02986516 | Recruiting

• 1 other identifier: ISG SACRO
• Study Type: interventional
• Target: 100
• Locations: 10 countries
• Sites: 28

Brief Summary

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

Conditions

Chordoma

Outcome Measures

Primary Outcomes (1)

• Relapse Free Survival (RFS)

  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 Outcomes (9)

• Overall Survival (OS)

  The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years)

• Survival Post Progression (SPP)

  Expected average: 36 months

• Local Relapse Failure (LRF)

  Expected average: 60 months

• Distant Relapse Failure (DRF)

  Expected average: 60 months

• Best Response rate to definitive radiotherapy

  At 12 months, 2 years and 5 years after radiotherapy

Study Arms (2)

Randomized Cohort

EXPERIMENTAL

Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment

Other: Randomized Cohort

Prospective Cohort

ACTIVE COMPARATOR

Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice

Radiation: Prospective cohort

Interventions

Randomized Cohort OTHER

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

Randomized Cohort

Prospective cohort RADIATION

Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated

Prospective Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (28)

Medical University of Graz

Graz, Austria

RECRUITING

EBG GmbH MedAustron

Wiener Neustadt, Österreich, 2700, Austria

RECRUITING

Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,

Dresden, Germany

NOT YET RECRUITING

University Hospital Carl Gustav Carus Dresden

Dresden, Germany

NOT YET RECRUITING

University Hospital Essen. West German Proton Therapy Center Essen

Essen, Germany

RECRUITING

Heidelberg Ion-Beam Therapy Center - HIT

Heidelberg, Germany

NOT YET RECRUITING

National Center for Spinal Disorders

Budapest, Hungary

NOT YET RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, 20133, Italy

RECRUITING

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

NOT YET RECRUITING

Istituto Clinico Humanitas

Milan, 20089, Italy

RECRUITING

I.R.C.C.S. Istituto Ortopedico Galeazzi

Milan, 20161, Italy

ACTIVE NOT RECRUITING

Centro Nazionale di Adroterapia Oncologica - CNAO

Pavia, 27100, Italy

RECRUITING

II Clinica Universitaria Ortopedia e Traumatologia AO Pisa

Pisa, 56124, Italy

RECRUITING

Istituto Regina Elena - IFO

Rome, 00100, Italy

RECRUITING

Agenzia Provinciale per la Protonterapia - AtreP

Trento, 38122, Italy

ACTIVE NOT RECRUITING

Saitama Medical Center

Saitama, Japan

RECRUITING

Netherlands Cancer Institute

Amsterdam, Netherlands

NOT YET RECRUITING

Leiden University Medical Center

Leiden, Netherlands

NOT YET RECRUITING

Norwegian Radium Hospital/Oslo Univeristi Hospital

Oslo, N-0424, Norway

RECRUITING

Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

Warsaw, Poland

ACTIVE NOT RECRUITING

H. Val D'Hebron

Barcelona, Spain

RECRUITING

Hosptial San Pau

Barcelona, Spain

ACTIVE NOT RECRUITING

H. San Carlos

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

RECRUITING

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

NOT YET RECRUITING

The Royal Orthopaedic Hospital

Birmingham, United Kingdom

NOT YET RECRUITING

Royal National Orthopaedic Hospital

London, United Kingdom

NOT YET RECRUITING

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MeSH Terms

Conditions

Chordoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Alessandro Gronchi, MD

  Istituto Nazionale Tumori Milan-Italy

  PRINCIPAL INVESTIGATOR

• Piero Fossati, MD

  MedAustron Graz-Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Gronchi, MD

CONTACT

+390223903714; alessandro.gronchi@istitutotumori.mi.it

ISG Clinical Trial Center

CONTACT

clinicaltrials@italiansarcomagroup.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 8, 2016
• Study Start: March 16, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); JP (1); ES (5); PL (1); DE (4); GB (2); NL (2); IT (9); NO (1); AU (2)