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

Chordoma Clinical Trial

— SACRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02986516
• Other study ID #: ISG SACRO
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2017
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Italian Sarcoma Group
• Contact: Alessandro Gronchi, MD
• Phone: +390223903714
• Email: alessandro.gronchi[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chordoma

Intervention

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

Radiation:
• Prospective cohort
Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	EBG GmbH MedAustron	Wiener Neustadt	Österreich
Germany	Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,	Dresden
Germany	University Hospital Carl Gustav Carus Dresden	Dresden
Germany	University Hospital Essen. West German Proton Therapy Center Essen	Essen
Germany	Heidelberg Ion-Beam Therapy Center - HIT	Heidelberg
Hungary	National Center for Spinal Disorders	Budapest
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano	MI
Italy	I.R.C.C.S. Istituto Ortopedico Galeazzi	Milano
Italy	Istituto Clinico Humanitas	Milano
Italy	Centro Nazionale di Adroterapia Oncologica - CNAO	Pavia
Italy	II Clinica Universitaria Ortopedia e Traumatologia AO Pisa	Pisa
Italy	Istituto Regina Elena - IFO	Rome
Italy	Agenzia Provinciale per la Protonterapia - AtreP	Trento
Japan	Saitama Medical Center	Saitama
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Norway	Norwegian Radium Hospital/Oslo Univeristi Hospital	Oslo
Poland	Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie	Warsaw
Spain	H. Val D'Hebron	Barcelona
Spain	Hosptial San Pau	Barcelona
Spain	H. San Carlos	Madrid
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Doctor Peset	Valencia
United Kingdom	The Royal Orthopaedic Hospital	Birmingham
United Kingdom	Royal National Orthopaedic Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Countries where clinical trial is conducted

Austria,  Germany,  Hungary,  Italy,  Japan,  Netherlands,  Norway,  Poland,  Spain,  United Kingdom, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	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)
Secondary	Survival Post Progression (SPP)	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
Secondary	Local Relapse Failure (LRF)	The time from randomization or treatment start date to the date of local disease relapse	Expected average: 60 months
Secondary	Distant Relapse Failure (DRF)	The time from randomization or treatment start date to the date of distant disease relapse	Expected average: 60 months
Secondary	Best Response rate to definitive radiotherapy	Best Response rate to definitive radiotherapy	At 12 months, 2 years and 5 years after radiotherapy
Secondary	Time to best response rate to definitive radiotherapy	Time to best response rate to definitive radiotherapy	At 12 months, 2 years and 5 years after radiotherapy
Secondary	Adverse Events Incidence	Adverse Events incidence	At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy
Secondary	Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General	Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General	every 6 months (expected average: 5 years)
Secondary	Evaluation of quality of life measured with Brief Inventory Pain questionnaires	Evaluation of quality of life measured with Brief Inventory Pain questionnaires	every 6 months (expected average: 5 years)