2024-512456-38-00招募中2 期
A phase II randomized trial, non comparative, evaluating chemotherapy associated cisplatin, 5-fluorouracil and docetaxel at adapted doses in patients with locally advanced squamous cell carcinoma
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 13
- 主要终点
- Rate of patient success at 8 weeks
研究概览
简要总结
Evaluate the effectiveness of the combination of cisplatin-5FU-docetaxel at adapted doses (TPFm) in terms of response to treatment without toxicity.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, histologically proven (several ENT locations are authorized), lymphadenopathy without portal of entry
- •Tumor considered inoperable or for which surgery would be mutilating
- •Patient not previously treated for ORL cancer
- •Age > 18 years and < 75 years
- •PS 0 or 1 according to WHO
- •At least one measurable lesion according to RECIST 1.1 criteria
- •Patient able to receive TPF according to well-defined criteria
- •Estimated life expectancy greater than or equal to 3 months.
排除标准
- •Cancers of the nasopharynx, sinuses or nasal cavities, and any histology other than squamous cell carcinoma
- •Other existing serious medical pathologies
- •Known hypersensitivity to docetaxel, cisplatin 5FU or one of their excipients
- •Planned concomitant use of phenytoin, carbamazepine, barbiturates or rifampicin
- •Recent or planned yellow fever vaccination
- •Deficiency of dihydropyrimidine dehydrogenase (DPD) activity
- •History of other cancer except in situ cervical cancer or controlled basal cell carcinoma. Patients in remission from cancer treated more than 3 years ago are eligible. Patients treated with surgery alone for head and neck cancer in the previous 3 years are eligible.
- •Previous treatment of head and neck cancer by chemotherapy or radiotherapy (Patients treated by surgery alone for head and neck cancer in the previous 3 years are eligible).
- •Presence of distant metastasis.
- •Participation in a therapeutic trial within 30 days preceding randomization
- •Concomitant anticancer treatment
- •Patient under chronic treatment (3 months) with corticosteroid whose daily dosage is 10 mg/day of methylprednisolone or equivalent
结局指标
主要结局
Rate of patient success at 8 weeks
Rate of patient success at 8 weeks
次要结局
- Overall survival defined by the time between the date of randomization and the date of death from any cause. In the absence of notification of death, survival data will be censored on the date of last news without progression.
- Progression-free survival defined by the time between the date of randomization and the date of first evidence of progression, the date of death from any cause or the date of last news without progression.
- Rate of patients in local and/or locoregional control of the disease at week 8 ± 3 days.
- Rate of patients with larynx preservation. Is considered as total laryngectomy event.
- Metastasis-free survival defined by the time between the date of randomization and the date of first evidence of metastatic progression, or the date of death, whatever the cause.
- Toxicity of complementary treatment to induction treatment.
- Rate of patients who received the entire induction treatment.
- Rate of patients who received the entire complementary treatment to induction treatment.
- Hospitalization or extension of hospitalization for toxicity linked to the treatments under study.
- Quality of life according to the EORTC QLQ-C30 and EORTCH& N35 questionnaires
研究者
Jérôme FAYETTE
Scientific
Groupe Oncologie Radiotherapie Tete Cou
研究点 (13)
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