Spots Global Cancer Trial Database for Albumin-bound Paclitaxel Combined With Cisplatin Versus Docetaxel Combined With Cisplatin Induced Chemotherapy in Advanced Head and Neck Squamous Tummor

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Trial Identification

Brief Title: Albumin-bound Paclitaxel Combined With Cisplatin Versus Docetaxel Combined With Cisplatin Induced Chemotherapy in Advanced Head and Neck Squamous Tummor

Official Title: A Prospective Randomized Controlled Clinical Study of Albumin-bound Paclitaxel Combined With Cisplatin (AP Regimen) Versus Docetaxel Combined With Cisplatin (TP Regimen) Induced Chemotherapy in Advanced Head and Neck Squamous Tummor

Study ID: NCT04766827

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

albumin-bound paclitaxel

Study Description

Brief Summary: Research Topic: A prospective randomized controlled clinical study of albumin-bound paclitaxel combined with cisplatin (AP regimen) versus docetaxel combined with cisplatin (TP regimen) induced chemotherapy in advanced head and neck squamous cell carcinoma Expected study duration: Each subject received a 3-week regimen of AP or TP over 2 cycles. Research objectives: To evaluate the efficacy and safety of induction chemotherapy with albumin-bound paclitaxel in patients with advanced head and neck squamous cell carcinoma (HSCC), two induction chemotherapy regimens, AP regimen and TP regimen, were compared. Trial Design. Single center, open label, controlled clinical study Number of cases: 116 Objective response rate (ORR=CR+PR) was used as the main evaluation index in this study.

Detailed Description: Research purposes:Research the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma were evaluated,by comparing the AP regimen and the TP regimen . Research content:To evaluate the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma. Study endpoint Primary endpoint: Objective response rate (ORR=CR+PR) (Assessed according to RECIST standards, see Annex 1) Secondary study endpoint: Surgical resection rate,Pathological remission rate,Progression-free survival (PFS), Overall survival (OS) Main safety indicators: Observe any adverse events that occurred in all subjects during the clinical study and within 1 month after stopping the drug, including clinical symptoms, abnormal vital signs, and abnormalities in laboratory examinations, and record their clinical features, Severity, time of occurrence, duration, treatment method and prognosis outcome, and determine its correlation with the study drug. The safety of the drug was evaluated according to the NCI-CTC AE 4.0 standard. Study design:This is a single-center, open-label, controlled clinical study.The aime is observing and evaluating the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma. This study is planned to be carried out in Tianjin Cancer Hospital. According to the research principles of GCP. The study plans to recruit 116 qualified subjects. This study used objective response rate (ORR=CR+PR) as the main evaluation index. According to previous reports, the ORR of the TP group was 50%, and the ORR of the AP group was estimated to be 75%. The test level is set to 0.05 on one side, the test power is set to 0.8, and the estimated dropout rate is 20%. Using the Logrank-Lakatos algorithm, the total sample size is calculated to be 116 cases.