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

Sponsor

Guiyang Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03117257

Collaborator

(none)

144

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Head and Neck Squamous Cell Carcinoma	Drug: Lobaplatin Drug: Cisplatin	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 19, 2016

Anticipated Primary Completion Date :

Aug 19, 2019

Anticipated Study Completion Date :

Aug 20, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: the treatment group

docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy

Drug: Lobaplatin

Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy

Other Names:

Platinum

Active Comparator: the control group

TPF induction chemotherapy combined with cisplatin chemoradiotherapy

Drug: Cisplatin

Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy

Other Names:

cis-DDP; cis-Diammineplatinum(II) dichloride;

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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