Clinical trial • Phase III • Oncology|Other

ROPIVACAINE for Head and neck cancer

Phase III trial of ROPIVACAINE for Head and neck cancer.

Overview

Trial Therapeutic Area
Oncology|Other
Trial Disease
Head and neck cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-02-2025
First CTIS Authorization Date
28-05-2025

Trial design

Study arms include: ROPIVACAINE (test) — solution for injection (active substance: ropivacaine), max total dose listed 100 mg; SODIUM CHLORIDE (placebo) — solution for injection, max total dose listed 50 ml. Detailed dosing schedule not specified.-controlled Phase III trial across 7 sites in France.

Comparator
Study arms include: ROPIVACAINE (test) — solution for injection (active substance: ropivacaine), max total dose listed 100 mg; SODIUM CHLORIDE (placebo) — solution for injection, max total dose listed 50 ml. Detailed dosing schedule not specified.
Target Sample Size
346
Trial Duration For Participant
90

Eligibility

Recruits 346 Vulnerable populations not selected. Trial enrols adults only. Patients must receive oral information from a doctor and sign written consent. Patients with altered mental faculties or unable to give consent are excluded..

Pregnancy Exclusion
Pregnant or breastfeeding woman
Vulnerable Population
Vulnerable populations not selected. Trial enrols adults only. Patients must receive oral information from a doctor and sign written consent. Patients with altered mental faculties or unable to give consent are excluded.

Inclusion criteria

  • {"criterion_text":"- Adult patient undergoing ENT cancer surgery with cervicotomy\n- Patient having received oral information from a doctor and signed written consent\n- Affiliation to a social security scheme, Universal Medical Coverage (CMU)"}

Exclusion criteria

  • {"criterion_text":"- Patient refusal\n- Patient under AME\n- Altered mental faculties or patient unable to give consent\n- Allergy to local anesthetics\n- Severe respiratory pathology (altered respiratory function tests with 50% < FEV1 < 80%, FEV1/FVC < 70%, COPD stage 2 or more)\n- Preoperative SpO2 less than 92% in ambient air\n- Left heart failure NYHA 3 or more, impaired LVEF < 30% or less\n- Lower respiratory infection in the month preceding surgery\n- History of ENT cancer surgery with cervical lymph node dissection\n- Pregnant or breastfeeding woman"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Quantity of morphine consumed postoperatively (quantity of morphine titrated in postoperative room + administered by the PCA in mg and mg/kg/d).","definition_or_measurement_approach":"Measured as the quantity of morphine titrated in the postoperative room plus morphine administered by PCA, recorded in mg and mg/kg over the first 24 postoperative hours."}

Recruitment

Planned Sample Size
346
Recruitment Window Months
26
Consent Approach
Participants receive oral information from a doctor and must sign written consent. Only adults are eligible; patients unable to give consent (altered mental faculties) are excluded. (Subject information and informed consent form document available in trial documents.)

Geography

Total Number Of Sites
7
Total Number Of Participants
346

France

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
28-05-2025
Processing Time Days
71
Number Of Sites
7
Number Of Participants
346

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Anesthésie et réanimation
Principal Investigator Name
Elsa GIULY
Principal Investigator Email
elsagiuly@ap-hm.fr
Contact Person Name
Elsa GIULY
Contact Person Email
elsagiuly@ap-hm.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Anesthésie et réanimation
Principal Investigator Name
Jean SELIM
Principal Investigator Email
Jean.selim@chu-rouen.fr
Contact Person Name
Jean SELIM
Contact Person Email
Jean.selim@chu-rouen.fr
Site Name
Hospital Foch
Department Name
Anethésie et douleurs
Principal Investigator Name
Morgan LE GUEN
Principal Investigator Email
m.leguen@hopital-foch.com
Contact Person Name
Morgan LE GUEN
Contact Person Email
m.leguen@hopital-foch.com
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Anesthésie-réanimation chirurgicale
Principal Investigator Name
Laetitia DESPLANQUE
Principal Investigator Email
laetitia.desplanque@aphp.fr
Contact Person Name
Laetitia DESPLANQUE
Contact Person Email
laetitia.desplanque@aphp.fr
Site Name
Institut Gustave Roussy
Department Name
Anesthésie
Principal Investigator Name
Deborah TEMPESTA
Principal Investigator Email
Deborah.TEMPESTA@gustaveroussy.fr
Contact Person Name
Deborah TEMPESTA
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Anesthésie et réanimation
Principal Investigator Name
Sonia BOUKTHIR
Principal Investigator Email
sonia.boukthir@aphp.fr
Contact Person Name
Sonia BOUKTHIR
Contact Person Email
sonia.boukthir@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Anesthésie Réanimation Spécialités chirurgicales
Principal Investigator Name
Elsa JOZEFOWICZ
Principal Investigator Email
Elsa.jozefowicz@chu-lille.fr
Contact Person Name
Elsa JOZEFOWICZ
Contact Person Email
Elsa.jozefowicz@chu-lille.fr

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
ROPIVACAINE
Active Substance
ROPIVACAINE
Modality
Small molecule
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
No marketing authorisation (marketingAuthNumber: -)
Maximum Dose
100 mg
Investigational Product Name
SODIUM CHLORIDE
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
No marketing authorisation (marketingAuthNumber: -)
Maximum Dose
50 ml

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