UMIN ID: C000000097
Registered date:31/08/2005
A Randomized Phase II study of Carboplatin and Paclitaxel or Gemcitabine and Vinorelbine in ECOG PS2 patients with advanced non-small cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | ECOG PS2 patients with advanced non-small cell lung cancer |
| Date of first enrollment | 2001/07/01 |
| Target sample size | 90 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Carboplatin and paclitaxel Gemcitabine and vinorelbine |
Outcome(s)
| Primary Outcome | One-year survival rate |
|---|---|
| Secondary Outcome | Response rate, time to progression, safety,QOL |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Prior radiotherapy to evaluable disease unless subsequent progression at that site 2. Prior brain metastases if not clinically stable after surgery and/or radiotherapy 3. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <6 months before enrollment or congestive heart failure 4. Active concomitant malignancy requiring treatment. 5. Uncontrolled serious active infection 6. Pre-existing grade 2 neuropathy 7. Pregnancy or lactation |
Related Information
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichiro Nakamura |
| Address | 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan. Japan |
| Telephone | 06-6633-7400 |
| datacenter@wjog.jp | |
| Affiliation | West Japan Oncology Group WJOG datacenter |
| scientific contact | |
| Name | Hiroshi Saito, M.D. |
| Address | 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan. Japan |
| Telephone | 0564-21-6251 |
| Affiliation | Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine |