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

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

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.

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Nimotuzumab; Drug: Cisplatin

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Recruiting
      • Cancer Hospital of Guizhou Medical University
      • Contact: Feng Jin, Bachelor; Phone Number: 86-13985124806; Email: jinf8865@yahoo.com.cn
      • Sub-Investigator: Yu Chen, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Cancer Institute CTCAE v4.0	Acute toxicity of radiotherapy and chemotherapy	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of immediate efficacy overall survival overall survival overall survival overall survival overall survival overall survival	Evaluation of efficacy by RESIST1.1 standard	1 year
overall survival	Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST	5 years
locoregional failure-free survival	Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST	5 years
progression-free survival	Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST	5 years

Collaborators and Investigators

• Sponsor: Guiyang Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: cisplatin; chemoradiotherapy; nimotuzumab; Locally Advanced Nasopharyngeal Carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cisplatin; Nimotuzumab
• Other Study ID Numbers: 20180604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No