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

NCT ID: NCT03557112

Last Updated: 2018-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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the treatment group

TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

Group Type EXPERIMENTAL

Nimotuzumab

Intervention Type DRUG

TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

the control group

TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Interventions

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Nimotuzumab

TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

Intervention Type DRUG

Cisplatin

TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Intervention Type DRUG

Other Intervention Names

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Nimotuzumab lnjection cis-DDP; cis-Diammineplatinum(II) dichloride

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guiyang Medical University

OTHER

Sponsor Role lead

Responsible Party

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Feng Jing

Head and neck cancer director, chief researcher, clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feng Jin, Bachelor

Role: STUDY_CHAIR

Guizhou Provincial Cancer Hospital

Locations

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Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feng Jin, Bachelor

Role: CONTACT

86-13985124806

Weili Wu, master

Role: CONTACT

86-13885124077

Facility Contacts

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Feng Jin, Bachelor

Role: primary

86-13985124806

Weili Wu, Master

Role: backup

86-13885124077

Other Identifiers

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20180604

Identifier Type: -

Identifier Source: org_study_id

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