Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN

Study Overview
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Brief Summary
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This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.

Detailed Description
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TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients. Therefore, how to improve the efficacy of the same time to reduce adverse drug reactions, as a prominent problem. Lobaplatin as the third generation of platinum antitumor drugs, anti-cancer activity and cisplatin rather, more than carboplatin. In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.

Official Title
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A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Conditions
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Locally Advanced Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Lobaplatin
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary participation and written informed consent Age 18-70 years old, gender is not limited histologically proved to be squamous cell carcinoma No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period. After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients Karnofsky score ≥70 Survival is expected to be ≥ 6 months Women of childbearing age should be guaranteed contraception during the study period (WBC) ≥4 × 109 / L * (unit normal), platelet (PLT) ≥100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) ≥1.5 × 109 / L * (unit normal value) liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) <upper limit of normal (ULN) 1.5 times; total bilirubin <1.5 × ULN renal function: serum creatinine <1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months). Exclusion Criteria: There is a distant shift primary lesions or lymph nodes were radiotherapy had received epidermal growth factor targeted therapy primary tumor had received chemotherapy or immunotherapy had other malignancies (except for cured basal cell carcinoma or cervical cancer) pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age have a serious history of allergies or specific physical Abuse of drugs or alcohol addicts Person who has personality or mental illness, no civil capacity or limited civil capacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the treatment group<br>docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy | Drug: Lobaplatin<br>* Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy<br>* Other names: Platinum;|
| Active Comparator: the control group<br>TPF induction chemotherapy combined with cisplatin chemoradiotherapy | Drug: Cisplatin<br>* Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy<br>* Other names: cis-DDP; cis-Diammineplatinum(II) dichloride;;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Cancer Institute CTCAE v4.0 | Acute toxicity of radiotherapy and chemotherapy | 1 year | 
| evaluation of immediate efficacy | Evaluation of efficacy by RESIST1.1 standard | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST. | 5 years | 
| progression-free survival | Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lobaplatin, head and neck cancer, chronic-chemotherapy