Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Lobaplatin, head and neck cancer, chronic-chemotherapy
Brief summary
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
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.
Interventions
DRUGLobaplatin
Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
DRUGCisplatin
Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
Sponsors
Guiyang Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation and written informed consent 2. Age 18-70 years old, gender is not limited 3. histologically proved to be squamous cell carcinoma 4. 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 5. Karnofsky score ≥70 6. Survival is expected to be ≥ 6 months 7. Women of childbearing age should be guaranteed contraception during the study period 8. (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) 9. liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) \<upper limit of normal (ULN) 1.5 times; total bilirubin \<1.5 × ULN 10. renal function: serum creatinine \<1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min 11. no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history 12. The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months).
Exclusion criteria
1. There is a distant shift 2. primary lesions or lymph nodes were radiotherapy 3. had received epidermal growth factor targeted therapy 4. primary tumor had received chemotherapy or immunotherapy 5. had other malignancies (except for cured basal cell carcinoma or cervical cancer) 6. pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age 7. have a serious history of allergies or specific physical 8. Abuse of drugs or alcohol addicts 9. Person who has personality or mental illness, no civil capacity or limited civil capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Cancer Institute CTCAE v4.0 | 1 year | Acute toxicity of radiotherapy and chemotherapy |
| evaluation of immediate efficacy | 1 year | Evaluation of efficacy by RESIST1.1 standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST. |
| progression-free survival | 5 years | Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST. |
Countries
China
Contacts
Primary ContactFeng Jin, Bachelor
Backup ContactWeili Wu, master
Outcome results
None listed