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Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

NCT ID: NCT02972216

Last Updated: 2016-11-23

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

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Brief Summary

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A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy

Detailed Description

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Conditions

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Nonsmall Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Nolbaxol

For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60 \~ 75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study.

Nolbaxol

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Taxotere

For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60 \~ 75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study.

Taxotere

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Interventions

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Nolbaxol

Intervention Type DRUG

Taxotere

Intervention Type DRUG

cisplatin

Intervention Type DRUG

Other Intervention Names

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docetaxel docetaxel

Eligibility Criteria

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Inclusion Criteria

-Histologically or cytologically confirmed unresectable locally advanced NSCLC with progressed or recurred after no more than four previous docetaxel-free chemotherapy regimens, or unresectable locally advanced or metastatic SCCHN or recurred after previous docetaxel-free chemotherapy regimens

Exclusion Criteria

1. Women who are nursing or pregnant during the study period;
2. Patients with carcinoid tumors, small-cell carcinoma of the lung;
3. A history of another malignancy within the last five years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix);
4. Any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months);
5. Neutrophil counts \< 1,500 cells/mm3;
6. A history of hypersensitivity to docetaxel or cisplatin;
7. Symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias;
8. Subjects have active hepatitis;
9. Subjects are known positive for Human Immunodeficiency Virus (HIV);
10. Any condition judged by investigator, participates the study will jeopardize patient's wellbeing
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

Tri-Service General Hospital

OTHER

Sponsor Role collaborator

Yung Shin Pharm. Ind. Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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YSP RFH3001-01

Identifier Type: -

Identifier Source: org_study_id