Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease
Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
Italian Sarcoma Group
100 participants
Mar 16, 2017
INTERVENTIONAL
Conditions
Summary
Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma
Eligibility
Inclusion Criteria8
- 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 Criteria16
- 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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Interventions
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
Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated
Locations(28)
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NCT02986516