Clinical trial NCT03117257: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Keywords: Lobaplatin
head and neck cancer
chronic-chemotherapy
Lead sponsor: Guiyang Medical University
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: National Cancer Institute CTCAE v4.0
timeFrame: 1 year
measure: evaluation of immediate efficacy
timeFrame: 1 year
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: progression-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou Medical University
state: Guizhou
Study officials:
affiliation: Guizhou Provincial Cancer Hospital
name: Feng Jin, Bachelor
role: STUDY_CHAIR
References: