Paclitaxel for Head and neck squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- Age greater than or equal to 18 years at inclusion\n- Documented progression of a measurable tumor target according to RECIST 1.1\n- Correct biology\n- Cytological or histological confirmation of the diagnosis of invasive squamous cell carcinoma of the head and neck\n- One of the following locations: oral cavity, oropharynx (known p16 status), larynx or hypopharynx\n- Cancers of unknown primary (CUP) of the head and neck are accepted\n- Metastatic (stage IVc) or recurrent disease in patients ineligible for curative surgical treatment or radiotherapy\n- Indication of a second line after Immune checkpoint inhibitor with or without chemotherapy\n- Chemotherapy-free interval equal or greater than 3 months\n- ECOG Performance Index (Performance Index) of 0, 1 or 2\n- Patient with a life expectancy of at least 12 weeks"}

Exclusion criteria

• {"criterion_text":"- Other histology\n- Major surgery within 4 weeks (= 28 days) before the first administration of treatment. Local palliative surgery for isolated lesions is tolerated\n- Nasal, paranasal and nasopharyngeal cavities\n- Symptomatic or active brain parenchymal metastases or leptomeningeal tumors\n- Grade equal or greater than to 2 for neuropathy\n- Patients may have previously received radiation therapy. A minimum period of 2 weeks is necessary between palliative or analgesic radiotherapy and the start of treatment\n- Clinically significant heart disease or congestive heart failure NYHA (New York Heart Association) class 2 or greater. Patients must not have had unstable angina (symptoms of angina at rest) or new angina in the last 3 months or myocardial infarction in the last 6 months.\n- History of other primary malignancies\n- Known hypersensitivity to the active substance or excipient of the treatments under study\n- Any chemotherapy or radiation therapy performed within 4 weeks (= 28 days) of the first dose of study drug, except palliative radiation therapy to a non-target lesion"}

Primary endpoints

• {"endpoint_text":"- Number of patients who had an objective response within 12 months","definition_or_measurement_approach":"Best radiological response according to RECIST 1.1. Assessment by CT scan or MRI (PET-scan not validated for response evaluation). Evaluation is performed by the investigator."}

Secondary endpoints

• {"endpoint_text":"- Progression events (loco-regional progression, metastatic progression or death whatever the cause) will be collected beyond 12 months of patient participation according to local practices.","definition_or_measurement_approach":"Progression events collected beyond 12 months according to local practice. Evaluation by CT or MRI (PET not validated)."}
• {"endpoint_text":"- The patient's condition (alive, deceased from whatever cause or lost to follow-up) will be collected beyond 12 months of patient participation. Patients alive at the time of analysis will be censored on the date of last contact","definition_or_measurement_approach":"Vital status follow-up beyond 12 months (at least twice per year). Censoring: patients alive at analysis censored at date of last contact."}
• {"endpoint_text":"- Time from date of first documented response (complete or partial response) to date of first subsequent progression or death from any cause","definition_or_measurement_approach":"Duration of response measured from date of first documented response (complete or partial per RECIST 1.1) to date of first subsequent progression or death. Evaluation by CT or MRI (PET not validated)."}
• {"endpoint_text":"- Incidence of treatment-emergent adverse events, serious adverse events according to CTCAE V5.0 criteria and deaths","definition_or_measurement_approach":"Safety assessed by incidence of treatment-emergent adverse events and serious adverse events graded per CTCAE v5.0; collection of deaths."}
• {"endpoint_text":"- Taking the QLQ-C30 and QLQ-HN35 questionnaires","definition_or_measurement_approach":"Health-related quality of life assessed using EORTC QLQ-C30 and QLQ-HN35 questionnaires."}

France

Earliest CTIS Part Ii Submission Date

04-10-2024

Latest Decision Or Authorization Date

16-01-2026

Processing Time Days

469

Number Of Sites

5

Number Of Participants

46

Primary sponsor

Full Name

Centre Regional Lutte Contre Le Cancer

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France