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

October 31, 2018 updated by: Feng Jing, Guiyang Medical University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Recruiting
        • Cancer Hospital of Guizhou Medical University
        • Contact:
        • Sub-Investigator:
          • Yu Chen, master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guiyang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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