Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)
Randomized Phase II Study of the Induction Chemotherapy With Docetaxel Alone vs CDDP + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
2 other identifiers
interventional
80
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the preoperative docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2002
Longer than P75 for phase_2
1 active site
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
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 19, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedSeptember 22, 2016
September 1, 2016
6.1 years
August 19, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease-free survival rate at 1 year
during the study conduct
Secondary Outcomes (7)
overall survival
during the study conduct
disease-free survival
during the study conduct
treatment compliance
during the study conduct
response rate to chemotherapy
during the study conduct
pathologic complete response (CR) rate
during the study conduct
- +2 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALPreoperative docetaxel-cisplatin combination chemotherapy
2
ACTIVE COMPARATORPreoperative docetaxel monotherapy
Interventions
Preoperative docetaxel-cisplatin combination chemotherapy
Eligibility Criteria
You may qualify if:
- Newly diagnosed, pathologically documented NSCLC
- Clinical stages IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)
- Ages: 15-74 years old
- ECOG performance status 0 or 1
- Measurable disease
- Ample organ function
- Signed informed consent
You may not qualify if:
- Invasion to the first rib or more superior chest wall
- Metastasis to, or involvement of, mediastinal node
- Active concomitant malignancy
- Unstable angina, recent myocardial infarction, or heart failure
- Uncontrolled diabetes or hypertension
- Pregnant or lactating women
- Other severe complications
- Systemic use of corticosteroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haruhiko Fukudalead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (1)
National Cancer Center
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harubumi Kato, MD, PhD
Tokyo Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- JCOG Data Center
Study Record Dates
First Submitted
August 19, 2005
First Posted
August 22, 2005
Study Start
October 1, 2002
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
September 22, 2016
Record last verified: 2016-09