Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases (ZOSTER)

Institut Cancerologie de l'Ouest

Status and phase: Unknown; Phase 3

Conditions: Vertebral Metastasis

Treatments: Radiation: Hypo-fractured radiotherapy in stereotactic conditions; Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions

Study type: Interventional

Funder types: Other

Identifiers

NCT03951493

ICO-N-2018-14

Details and patient eligibility

About

Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.

Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

RSHF + zoledronic acid

Experimental group

Description:

Patients receive RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction. combined with zoledronic acid (4 mg IV slow monthly for 12 months, dose adjusted according to creatinine clearance).

Treatment:

Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions

RSHF

Active Comparator group

Description:

Patients receive only RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction.

Treatment:

Radiation: Hypo-fractured radiotherapy in stereotactic conditions