Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972216
• Other study ID #: YSP RFH3001-01
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2016
• Last updated: November 21, 2016
• Start date: November 2014

Study information

• Verified date: November 2016
• Source: Yung Shin Pharm. Ind. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Nonsmall Cell Lung Cancer
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• Nolbaxol

• Taxotere

• cisplatin

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Yung Shin Pharm. Ind. Co., Ltd.	National Cheng-Kung University Hospital, Taichung Veterans General Hospital, Tri-Service General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)		Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.	No
Secondary	Overall Response Rate (ORR)		Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.	Yes
Secondary	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.	Yes