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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the treatment group | Experimental | docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy |
|
| the control group | Active Comparator | TPF induction chemotherapy combined with cisplatin chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lobaplatin | Drug | Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy |
|
| 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 |
| 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. |
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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 â…¢ - â…£A, â…£B period.
After surgery: 2010UICC staging â…£A, â…£B;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) \
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Jin, Bachelor | Contact | 86-851-86512802 | jinf8865@yeah.net | |
| Weili Wu, master | Contact | 86-13885124077 | wwlmhy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Jin, Bachelor | Guizhou Provincial Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37985501 | Derived | Zhang M, Chen Y, Wu W, Jin F, Li Y, Long J, Luo X, Gong X, Chen X, Liu L, Tang H, Wang Z. A prospective phase II randomized study of docetaxel combined with lobaplatin versus TPF regimen induction chemotherapy followed by concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma. J Cancer Res Clin Oncol. 2023 Dec;149(20):18081-18091. doi: 10.1007/s00432-023-05497-1. Epub 2023 Nov 20. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C066228 | lobaplatin |
| D010984 | Platinum |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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|
| Cisplatin | Drug | Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy |
|
|
| 5 years |
| D008670 |
| Metals |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |