Chordoma
Conditions
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
Interventions
OTHERRandomized 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
RADIATIONProspective cohort
Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated
Sponsors
Italian Sarcoma Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Best Response rate to definitive radiotherapy | At 12 months, 2 years and 5 years after radiotherapy | Best Response rate to definitive radiotherapy |
| 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 |
| Adverse Events Incidence | At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy | Adverse Events incidence |
| 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 |
| 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 |
| 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 |
Countries
Austria, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Spain, United Kingdom
Contacts
Primary ContactAlessandro Gronchi, MD
Backup ContactISG Clinical Trial Center
Outcome results
None listed