Clinical trial • Phase III • Oncology
Clinical trial in Anaesthesia for free flap breast reconstruction
Phase III trial for Anaesthesia for free flap breast reconstruction.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Anaesthesia for free flap breast reconstruction
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 01-04-2024
- First CTIS Authorization Date
- 07-05-2024
Trial design
Randomised, opioid-based anaesthesia (standard care) versus opioid-free anaesthesia; doses/schedule not specified.-controlled Phase III trial across 3 sites in France.
- Randomised
- Yes
- Comparator
- Opioid-based anaesthesia (standard care) versus opioid-free anaesthesia; doses/schedule not specified.
- Target Sample Size
- 158
Eligibility
Recruits 158 No vulnerable population selected; trial includes adult female patients only; consent or assent handling not specified..
- Vulnerable Population
- No vulnerable population selected; trial includes adult female patients only; consent or assent handling not specified.
Recruitment
- Planned Sample Size
- 158
- Recruitment Window Months
- 48
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 158
France
- Earliest CTIS Part Ii Submission Date
- 19-04-2024
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 612
- Number Of Sites
- 3
- Number Of Participants
- 158
Sites
- Site Name
- Institut Curie
- Department Name
- Anesthésie
- Principal Investigator Name
- Migena DEMIRI
- Principal Investigator Email
- migena.demiri@gustaveroussy.fr
- Contact Person Name
- Migena DEMIRI
- Contact Person Email
- migena.demiri@gustaveroussy.fr
- Site Name
- Institut Curie
- Department Name
- Anesthésie
- Principal Investigator Name
- Jane MURET
- Principal Investigator Email
- jane.muret@curie.fr
- Contact Person Name
- Jane MURET
- Contact Person Email
- jane.muret@curie.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Anesthésie
- Principal Investigator Name
- Mary SAAD
- Principal Investigator Email
- mary.saad@curie.fr
- Contact Person Name
- Mary SAAD
- Contact Person Email
- mary.saad@curie.fr
Sponsor
Primary sponsor
- Full Name
- Institut Curie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)