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

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Cisplatin; Drug: Nimotuzumab

• Registration Number: NCT03557112
• Lead Sponsor: Guiyang Medical University

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.

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 Timeline

• Status Verified: 2018-06
• Study Start: 2018-06-01
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-14
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-02
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. The pathological type is non-keratinizing cancer (according to the World Health Organization, WHO pathological classification).
2. The stage is graded by TxNxM0 (according to the eighth edition of the AJCC staging standard).
3. Age: Between 18 to 70.
4. EGFR, which is performed by biopsy immunohistochemical examination, shows positive.
5. Functional Status: Karnofsky Scale (KPS) > 70.
6. Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.
7. 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.
8. Normal Renal Function: creatinine clearance > 60 ml/min.
9. The patient must be informed of the basic content of the study and sign an informed consent.

Exclusion Criteria

1. Patients with a prior history of malignant tumors, except well-treated basal cell carcinoma or squamous-cell carcinoma, and cervical carcinoma in situ.
2. Women during pregnancy or breastfeeding (for women of child-bearing age, pregnancy test should be considered; effective contraception should be emphasized during treatment).
3. Patients received radiotherapy, chemotherapy, and immunological targeted therapies (non-melanoma skin cancers with previous lesions outside the target of radiotherapy are excluded).
4. Patients received treatments for primary lesions and metastatic cervical lesions (except diagnostic treatment).
5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group	Cisplatin	TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
the treatment group	Nimotuzumab	TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
National Cancer Institute CTCAE v4.0	1 year	Acute toxicity of radiotherapy and chemotherapy

Secondary Outcome Measures

Name	Time	Method
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
overall survival	5 years	Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
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

Trial Locations

Locations (1)

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