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

Launched by ITALIAN SARCOMA GROUP · Dec 5, 2016

Keywords

ClinConnect Summary

This clinical trial is comparing two treatment options for patients with sacral chordoma, a type of cancer that occurs in the bone at the base of the spine. The study is looking at how effective surgery is compared to radiation therapy for patients who have localized (not spread) tumors. The trial is currently recruiting participants aged 18 and older who have been diagnosed with sacral chordoma and have not received previous cancer treatments. To be eligible, patients must have a tumor that can be seen on an MRI or CT scan and should be able to tolerate either surgery or radiation therapy.

Participants in this trial can expect to contribute valuable information that may help doctors understand which treatment option is better for this type of cancer. They will need to provide written consent to join the study and will be monitored throughout the treatment process. It is important to note that patients with certain health conditions, previous cancer treatments, or those who are pregnant or breastfeeding will not be eligible to participate. This trial aims to find the best approach to treating sacral chordoma, and each participant's involvement could make a significant difference in future treatment options for others.

Gender

ALL

Eligibility criteria

• 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