UMIN ID: UMIN000008928
Registered date:19/09/2012
A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | non-squamous non-small cell lung cancer |
| Date of first enrollment | 2010/12/24 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Four cycles of Pemetrexed+ Carboplatin followed by maintenance Pemetrexed in 3 weeks cycles until progression disease Four cycles of Pacritaxel followed by maintenance Pemetrexed in 3 weeks cycles until progression disease |
Outcome(s)
| Primary Outcome | Progression Free Survival (PFS) |
|---|---|
| Secondary Outcome | Response rate (RR), Disease control rate (DCR) overall survival (OS), Safety |
Key inclusion & exclusion criteria
| Age minimum | 75years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Apparent interstitial pneumonia or pulmonary fibrosis detectable on Chest CT 2) Serious complications as follows; 1.Uncontrollable angina pectoris, acute myocardial infarction or congestive heart failue, etc within 1 year 2.Uncontrollable diabetes mellitus and hypertenson 3.Active infectious disease 4. intestinal paralysis or intestinal obstruction 5. Other Serious complications 3) Patiens has pleural effusion, pericardial effusion and ascites to need treatment 4) symptomatic brain metastasis 5) SVC syndrome 6) Active double cancer 7) Pregnancy, breast feeding and suspected or wish of pregnancy 8) Patients who have serious drug hypersensitivity reaction 9) Patients whose participation in the trial is judged to be inappropriate because of psychiatric disease or psychiatric symptoms 10) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor |
Related Information
| Primary Sponsor | Yushima Lung Cancer Oncology Group(YLOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Integrated Pulmonology, Tokyo Medical and Dental university |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroyuki Sakashita |
| Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | |
| Affiliation | Tokyo Medical and Dental university Department of Integrated Pulmonology |
| scientific contact | |
| Name | Naohiko Inase |
| Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | |
| Affiliation | Tokyo Medical and Dental university Department of Integrated Pulmonology |