Clinical trial NCT02986516: Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease
Official title: Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chordoma
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2016-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Relapse Free Survival (RFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years)
measure: Survival Post Progression (SPP)
timeFrame: Expected average: 36 months
measure: Local Relapse Failure (LRF)
timeFrame: Expected average: 60 months
measure: Distant Relapse Failure (DRF)
timeFrame: Expected average: 60 months
measure: Best Response rate to definitive radiotherapy
timeFrame: At 12 months, 2 years and 5 years after radiotherapy
measure: Time to best response rate to definitive radiotherapy
timeFrame: At 12 months, 2 years and 5 years after radiotherapy
measure: Adverse Events Incidence
timeFrame: At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy
measure: Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General
timeFrame: every 6 months (expected average: 5 years)
measure: Evaluation of quality of life measured with Brief Inventory Pain questionnaires
timeFrame: every 6 months (expected average: 5 years)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Wiener Neustadt
country: Austria
facility: EBG GmbH MedAustron
state: Österreich
city: Dresden
country: Germany
facility: Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus Dresden
city: Essen
country: Germany
facility: University Hospital Essen. West German Proton Therapy Center Essen
city: Heidelberg
country: Germany
facility: Heidelberg Ion-Beam Therapy Center - HIT
city: Budapest
country: Hungary
facility: National Center for Spinal Disorders
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: MI
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Milano
country: Italy
facility: Istituto Clinico Humanitas
city: Milano
country: Italy
facility: I.R.C.C.S. Istituto Ortopedico Galeazzi
city: Pavia
country: Italy
facility: Centro Nazionale di Adroterapia Oncologica - CNAO
city: Pisa
country: Italy
facility: II Clinica Universitaria Ortopedia e Traumatologia AO Pisa
city: Rome
country: Italy
facility: Istituto Regina Elena - IFO
city: Trento
country: Italy
facility: Agenzia Provinciale per la Protonterapia - AtreP
city: Saitama
country: Japan
facility: Saitama Medical Center
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Oslo
country: Norway
facility: Norwegian Radium Hospital/Oslo Univeristi Hospital
city: Warsaw
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
city: Barcelona
country: Spain
facility: H. Val D'Hebron
city: Barcelona
country: Spain
facility: Hosptial San Pau
city: Madrid
country: Spain
facility: H. San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital
city: London
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
affiliation: Istituto Nazionale Tumori Milan-Italy
name: Alessandro Gronchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedAustron Graz-Austria
name: Piero Fossati, MD
role: PRINCIPAL_INVESTIGATOR
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