Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease
- Conditions
- Chordoma
- Interventions
- Other: Randomized CohortRadiation: Prospective cohort
- Registration Number
- NCT02986516
- Lead Sponsor
- Italian Sarcoma Group
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized Cohort Randomized Cohort Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment Prospective Cohort Prospective cohort Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice
- Primary Outcome Measures
Name Time Method Relapse Free Survival (RFS) 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
Name Time Method Survival Post Progression (SPP) 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) Expected average: 60 months The time from randomization or treatment start date to the date of local disease relapse
Distant Relapse Failure (DRF) Expected average: 60 months The time from randomization or treatment start date to the date of distant disease relapse
Time to best response rate to definitive radiotherapy At 12 months, 2 years and 5 years after radiotherapy Time to best response rate to definitive radiotherapy
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 Functional Assessment of Cancer Therapy General
Best Response rate to definitive radiotherapy At 12 months, 2 years and 5 years after radiotherapy Best Response rate to definitive radiotherapy
Evaluation of quality of life measured with Brief Inventory Pain questionnaires every 6 months (expected average: 5 years) Evaluation of quality of life measured with Brief Inventory Pain questionnaires
Adverse Events Incidence At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy Adverse Events incidence
Overall Survival (OS) 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
Trial Locations
- Locations (28)
Istituto Clinico Humanitas
🇮🇹Milano, Italy
Hosptial San Pau
🇪🇸Barcelona, Spain
Medical University of Graz
🇦🇹Graz, Austria
EBG GmbH MedAustron
🇦🇹Wiener Neustadt, Österreich, Austria
Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
🇩🇪Dresden, Germany
Heidelberg Ion-Beam Therapy Center - HIT
🇩🇪Heidelberg, Germany
University Hospital Essen. West German Proton Therapy Center Essen
🇩🇪Essen, Germany
University Hospital Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
National Center for Spinal Disorders
🇭🇺Budapest, Hungary
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, MI, Italy
Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Italy
Istituto Regina Elena - IFO
🇮🇹Rome, Italy
I.R.C.C.S. Istituto Ortopedico Galeazzi
🇮🇹Milano, Italy
II Clinica Universitaria Ortopedia e Traumatologia AO Pisa
🇮🇹Pisa, Italy
Centro Nazionale di Adroterapia Oncologica - CNAO
🇮🇹Pavia, Italy
Agenzia Provinciale per la Protonterapia - AtreP
🇮🇹Trento, Italy
Saitama Medical Center
🇯🇵Saitama, Japan
Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
H. Val D'Hebron
🇪🇸Barcelona, Spain
Norwegian Radium Hospital/Oslo Univeristi Hospital
🇳🇴Oslo, Norway
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
🇵🇱Warsaw, Poland
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
The Royal Orthopaedic Hospital
🇬🇧Birmingham, United Kingdom
Royal National Orthopaedic Hospital
🇬🇧London, United Kingdom
H. San Carlos
🇪🇸Madrid, Spain