Status:
UNKNOWN
Albumin-bound Paclitaxel Combined With Cisplatin Versus Docetaxel Combined With Cisplatin Induced Chemotherapy in Advanced Head and Neck Squamous Tummor
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 chemo...
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 compari...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥18 years old, male or female;
- Subjects had squamous cell carcinoma of the head and neck confirmed by histrohistology or cytology;
- CLINICAL STAGE III OR IV WITHOUT DISTANT METASTASES (AJCC 8th)
- Patients who have not previously received initial treatment with chemotherapy or radiation;
- KPS acuity 70;
- Normal bone marrow reserve function and normal liver and kidney function;
- Expected survival time ≥3 months;
- 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;
- Subjects have good compliance, can carry out treatment and follow-up, and voluntarily abide by the regulations of this study;
- Subjects voluntarily sign the informed consent.
Exclusion
- Exclusion criteria:
- Patients with distant metastasis;
- The presence of uncontrolled serious medical diseases, such as combined with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- The presence of dementia, altered mental status or any mental illness that would prevent understanding or giving informed consent or filling out questionnaires;
- Subjects with grade ≥2 peripheral neuropathy according to CTCAE V5.0;
- A history of allergy or hypersensitivity to any therapeutic ingredient;
- Suffered from malignant tumors other than squamous cell carcinoma of the head and neck in the past 5 years, except adequately treated basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
- Abnormal results of physical and laboratory tests:
- A) Hematologic abnormalities are defined as:
- I) Absolute count of neutrophils (ANC) : \< 1.5×109 / L; Ii) Platelet (PLT) count: \< 100×109/L; Iii) Hemoglobin (Hb) level \< 90g/L;
- B) Abnormal liver function is defined as:
- I) Total bilirubin (TBIL) level: 1.5 times of the upper limit of normal value of \> (ULN); Ii) AST and ALT levels of \>ULN were 2.5 times, and BBB\>N was 5 times if liver metastasis was present;
- C) Definition of abnormal renal function:
- 5 times of serum creatinine \> ULN, or the calculated creatinine clearance rate \< 50ml/min;
- Patients who need to be treated with other anti-tumor drugs;
- Has received any other investigational drug therapy or participated in another interventional clinical trial within 30 days prior to screening;
- The researcher considers it unsuitable for inclusion;
- Pregnant or lactating women.
Key Trial Info
Start Date :
December 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04766827
Start Date
December 12 2020
End Date
December 1 2021
Last Update
February 23 2021
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300000