Overview
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
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