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

Phase 2

• Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Lobaplatin; Drug: Cisplatin

• Registration Number: NCT03117257
• Lead Sponsor: Guiyang Medical University

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.

Study Timeline

• Study Start: 2016-08-19
• Status Verified: 2017-04
• Study First Submitted: 2017-04-02
• Study First Submitted QC: 2017-04-14
• Last Update Submitted: 2017-04-14
• Study First Posted: 2017-04-17
• Last Update Posted: 2017-04-17
• Primary Completion: 2019-08-19
• Study Completion: 2021-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the treatment group	Lobaplatin	docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy
the control group	Cisplatin	TPF induction chemotherapy combined with cisplatin chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
progression-free survival	5 years	Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
overall survival	5 years	Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.

Trial Locations

Locations (1)

Cancer Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China