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

Summary

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

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

Conditions2

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