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

STATUS

Recruiting
End date

Sep 18, 2024
participants needed

100
sponsor

Italian Sarcoma Group

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Updated on 18 September 2023

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ct scan

antineoplastic

proton therapy

Summary

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

Details

Condition	Chordoma
Treatment	Randomized Cohort, Prospective cohort
Clinical Study Identifier	NCT02986516
Sponsor	Italian Sarcoma Group
Last Modified on	18 September 2023

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Eligibility		Yes	No	Not Sure
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

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