UMIN ID: UMIN000000913
Registered date:29/11/2007
Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Non Small Cell Lung Cancer |
| Date of first enrollment | 2007/11/01 |
| Target sample size | 102 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | adjuvant chemotherapy with CDDP+GEM adjuvant chemotherapy with CBDCA+GEM |
Outcome(s)
| Primary Outcome | 2-year relapse free survival |
|---|---|
| Secondary Outcome | Safety Feasibility Overall survival time |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. sever infection 2. uncontrolled Diabetes Mellitus and hypertension, unstable angina or Myocardial Infarction within 6 months 3. apparent interstitial pneumonitis at chest rentogenogram 4. Uncontrollable pleural effusion 5. multiple lung cancer or other-type cancer within 5 years 6. History of severe hypersensitivity 7. Pregnant or expecting woman |
Related Information
| Primary Sponsor | Hokkaido Lung Cancer Clinical Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shin-ichi Fukumoto |
| Address | 4-2-3-54, kikusui, Shiroishi-ku, Sapporo 003-0804, Japan Japan 0030804 |
| Telephone | 011-811-9111 |
| fukumoto.shinichi.ad@mail.hosp.go.jp | |
| Affiliation | Hokkaido Lung Cancer Clinical Study Group Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center |
| scientific contact | |
| Name | Masao Harada |
| Address | 4-2-3-54, kikusui, Shiroishi-ku, Sapporo 003-0804, Japan Japan |
| Telephone | 011-811-9111 |
| fukumoto.shinichi.ad@mail.hosp.go.jp | |
| Affiliation | Hokkaido Lung Cancer Clinical Study Group Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center |