NCT01874678

Brief Summary

Objectives:

  1. 1.Primary Objective:
  2. 2.Secondary Objectives:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

4.8 years

First QC Date

June 4, 2013

Last Update Submit

January 10, 2016

Conditions

Non-small-cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    To assess overall response rate

    2 year

Secondary Outcomes (1)

  • To assess progression free survival To assess overall survival To bridge the safety profile by assessing the toxicities and tolerability

    2 year

Study Arms (1)

TS-1/Cisplatin

EXPERIMENTAL

single arm

Drug: TS-1/Cisplatin

Interventions

TS-1/CisplatinDRUG
TS-1/Cisplatin

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically or cytologically confirmed non-small cell bronchogenic carcinoma
  • Stage IIIb or IV disease
  • 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
  • performance status of ECOG 0, 1
  • age between 20 and 74 years at registration
  • life expectancy of at least 12 weeks
  • ability to take the oral study medication (TS-1)
  • voluntarily signed the written informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dalin Tzu Chi General Hospital

Chiayi City, Taiwan

Location

E-Da Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (2)

  • Okamoto I, Yoshioka H, Morita S, Ando M, Takeda K, Seto T, Yamamoto N, Saka H, Asami K, Hirashima T, Kudoh S, Satouchi M, Ikeda N, Iwamoto Y, Sawa T, Miyazaki M, Tamura K, Kurata T, Fukuoka M, Nakagawa K. Phase III trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer: results of a west Japan oncology group study. J Clin Oncol. 2010 Dec 20;28(36):5240-6. doi: 10.1200/JCO.2010.31.0326. Epub 2010 Nov 15.

    PMID: 21079147BACKGROUND

  • Ichinose Y, Yoshimori K, Sakai H, Nakai Y, Sugiura T, Kawahara M, Niitani H. S-1 plus cisplatin combination chemotherapy in patients with advanced non-small cell lung cancer: a multi-institutional phase II trial. Clin Cancer Res. 2004 Dec 1;10(23):7860-4. doi: 10.1158/1078-0432.CCR-04-1200.

    PMID: 15585618BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 11, 2013

Study Start

March 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

TW(5)