Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT03951493
Eligibility Criteria:
Inclusion Criteria:
* Cancer with inoperable thoracic and/or lumbar vertebral metastasis;
* Age ≥ 18 years old ;
* Life expectancy greater than 1 year;
* OMS or PS ≤ 2 ;
* Effective contraception for women of childbearing age;
* Patient information and free, informed and written consent, signed by the patient and investigator;
* Patient affiliated or beneficiary of the social security system.
Exclusion Criteria:
* Cancer with inoperable thoracic and/or lumbar vertebral metastasis;
* Painful patient unable to maintain a lying position for 30 minutes despite analgesic treatment;
* Patient who has received external irradiation from the proposed irradiation area \> 20 Gy ;
* Signs of neurological compression;
* Spinal cord compression or epidural damage requiring surgery before radiotherapy;
* Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any excipient;
* History of osteonecrosis of the maxilla or bone exposure or delayed healing after dental surgery;
* Previous (less than 2 years) or ongoing treatment with a bisphosphonate;
* Creatinine clearance \< 30 ml/min;
* Pregnant or breastfeeding woman;
* Patient protected or under guardianship or incapable of giving consent;
* Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03951493
Study Brief:
Protocol Section:
NCT03951493