Squamous Cell Carcinoma of Head and Neck
Conditions
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.
Interventions
DRUGalbumin-bound paclitaxel
Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
A prospective randomized controlled clinical trail
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: 1. Age ≥18 years old, male or female; 2. Subjects had squamous cell carcinoma of the head and neck confirmed by histrohistology or cytology; 3. CLINICAL STAGE III OR IV WITHOUT DISTANT METASTASES (AJCC 8th) 4. Patients who have not previously received initial treatment with chemotherapy or radiation; 5. KPS acuity 70; 6. Normal bone marrow reserve function and normal liver and kidney function; 7. Expected survival time ≥3 months; 8. Subjects of child-bearing age must agree to use effective contraceptive measures during the study period; The serum or urine pregnancy test must be negative for women of childbearing age 72 hours before the start of chemotherapy; 9. Subjects have good compliance, can carry out treatment and follow-up, and voluntarily abide by the regulations of this study; 10. Subjects voluntarily sign the informed consent.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 21 days | ORR=CR+PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical resection rate | 1 month | the rate of Surgical resection in all samples |
| pathological response rate | 1 month | the rate of pathological response in all samples |
| PFS | 5 year | progression-free survival |
| OS | 5 year | overall survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 90 days | Incidence of adverse events |
Countries
China
Contacts
Primary ContactXudong Wang, MD
Backup ContactZe Zhang, MD
Outcome results
None listed