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A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDNA

A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer

NCT01874678•TTY Biopharm

Summary

Objectives: 1. Primary Objective: To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin in Taiwanese advanced NSCLC patients from that gained from Japanese population 2. Secondary Objectives: A. To assess progression free survival B. To assess overall survival C. To bridge the safety profile by assessing the toxicities and tolerability

Eligibility

Age

20 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•To be eligible for inclusion, each subject must fulfill all of the following criteria:
•1. histologically or cytologically confirmed non-small cell bronchogenic carcinoma
•2. Stage IIIb or IV disease
•3. presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥20 mm with conventional CT/MRI or ≥10 mm with spiral CT scan
•4. performance status of ECOG 0, 1
•5. age between 20 and 74 years at registration
•6. life expectancy of at least 12 weeks
•7. ability to take the oral study medication (TS-1)
•8. voluntarily signed the written informed consent form.

Exclusion Criteria

•other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study
•previously received chemotherapy or therapy with systemic anti-tumor effect
•significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
•fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
•Presence of mental disease or psychotic manifestation
•Participation in another clinical trial with any investigational drug within 30 days prior to entry
•judged ineligible by physicians for participation in the study due to safety concern.

Locations (5)

Dalin Tzu Chi General Hospital

Chiayi City, Taiwan

E-Da Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Key Dates

Start Date

March 1, 2011

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

January 12, 2016

Enrollment

ACTUAL participants

Conditions

Non-small-cell Lung Cancer (NSCLC)

Interventions

TS-1/Cisplatin

DRUG

Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer

NCT02448992

Non-Small-Cell Lung Cancer (NSCLC)Brain Metastasis

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COMPLETED

A Study to Reveal the Patient Characteristics and Treatment Patterns of Stage III Non-small-cell Lung Cancer Patients

NCT03725475

Non-small-cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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