By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC

Sponsor

Guiyang Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03557112

Collaborator

(none)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is aimed to investigate the short-term efficacy and toxicities of local advanced nasopharyngeal carcinoma (NPC) treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and cisplatin concurrent chemoradiotherapy.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: Nimotuzumab Drug: Cisplatin	Phase 2

Detailed Description

TPF program is currently the local advanced nasopharyngeal 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.In this study, Phase II clinical trials were performed. Patients with locally advanced local advanced nasopharyngeal carcinoma were nonrandomly divided into experimental group and control group.The trial group was treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and chemotherapy. The control group was treated with TPF regimen induction chemotherapy combined with Cisplatin concurrent radiotherapy and 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 :

180 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Prospective, Multicenter, and Nonrandomized Phase II Clinical Study on the Treatment of Locally Advanced NPC By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the treatment group TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy	Drug: Nimotuzumab TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy Other Names: Nimotuzumab lnjection
Active Comparator: the control group TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy	Drug: Cisplatin TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy Other Names: cis-DDP; cis-Diammineplatinum(II) dichloride

Arm

Intervention/Treatment

Experimental: the treatment group

TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

Drug: Nimotuzumab

TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

Other Names:

Nimotuzumab lnjection

Active Comparator: the control group

TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Drug: Cisplatin

TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

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

Secondary Outcome Measures

evaluation of immediate efficacy overall survival overall survival overall survival overall survival overall survival overall survival [1 year]
Evaluation of efficacy by RESIST1.1 standard
overall survival [5 years]
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
locoregional failure-free survival [5 years]
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
progression-free survival [5 years]
Evaluate the Overall survival 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:

The pathological type is non-keratinizing cancer (according to the World Health Organization, WHO pathological classification).
The stage is graded by TxNxM0 (according to the eighth edition of the AJCC staging standard).
Age: Between 18 to 70.
EGFR, which is performed by biopsy immunohistochemical examination, shows positive.
Functional Status: Karnofsky Scale (KPS) > 70.
Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.
Normal Liver Function: Alanine Tminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5 times the upper limit of normal (ULN), while alkaline phosphatase (ALP) < 2.5 x ULN and bilirubin < ULN.
Normal Renal Function: creatinine clearance > 60 ml/min.
The patient must be informed of the basic content of the study and sign an informed consent.

Exclusion Criteria:

Patients with a prior history of malignant tumors, except well-treated basal cell carcinoma or squamous-cell carcinoma, and cervical carcinoma in situ.
Women during pregnancy or breastfeeding (for women of child-bearing age, pregnancy test should be considered; effective contraception should be emphasized during treatment).
Patients received radiotherapy, chemotherapy, and immunological targeted therapies (non-melanoma skin cancers with previous lesions outside the target of radiotherapy are excluded).
Patients received treatments for primary lesions and metastatic cervical lesions (except diagnostic treatment).
Patients with other serious diseases which may bring greater risk or affect the compliance of the trial. For example: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose >1.5 x ULN), and mental illness.