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

  • STATUS
    Recruiting
  • End date
    Sep 12, 2022
  • participants needed
    100
  • sponsor
    Italian Sarcoma Group
Updated on 12 August 2020
ct scan
antineoplastic

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
Treatment Randomized Cohort, Prospective cohort
Clinical Study IdentifierNCT02986516
SponsorItalian Sarcoma Group
Last Modified on12 August 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Germ Cell Tumors or Chordoma or Germ cell tumor?
Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx
Age18years
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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