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

NCT03557112 | Unknown Phase 2 DMC

• 1 other identifier: 20180604
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Locally Advanced Nasopharyngeal Carcinoma; nimotuzumab; chemoradiotherapy; cisplatin

Outcome Measures

Primary Outcomes (1)

• National Cancer Institute CTCAE v4.0

  Acute toxicity of radiotherapy and chemotherapy

  1 year

Secondary Outcomes (4)

• evaluation of immediate efficacy overall survival overall survival overall survival overall survival overall survival overall survival

  1 year

• overall survival

  5 years

• locoregional failure-free survival

  5 years

• progression-free survival

  5 years

Study Arms (2)

the treatment group

EXPERIMENTAL

TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

Drug: Nimotuzumab

the control group

ACTIVE COMPARATOR

TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Drug: Cisplatin

Interventions

Nimotuzumab DRUG

TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

Also known as: Nimotuzumab lnjection

the treatment group

Cisplatin DRUG

TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Also known as: cis-DDP; cis-Diammineplatinum(II) dichloride

the control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guiyang Medical University: lead

Study Sites (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nimotuzumab; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Feng Jin, Bachelor

  Guizhou Provincial Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Feng Jin, Bachelor

CONTACT

86-13985124806; jinf8865@yeah.net

Weili Wu, master

CONTACT

86-13885124077; wwlmhy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and neck cancer director, chief researcher, clinical professor

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)