Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02972216

Enrollment

Registered

2016-11-23

Start date

2014-11-30

Completion date

Unknown

Last updated

2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

DRUGNolbaxol

DRUGTaxotere

DRUGcisplatin

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS)	Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.

Secondary

Measure	Time frame
Overall Response Rate (ORR)	Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.
Adverse Events as a measure on safety	Adverse event will be evaluated during the study regimens treatment period and up to 8 weeks after the last dose of study regimen visit.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026