UMIN ID: UMIN000001236
Registered date:01/08/2008
Phase II study in combination with Carboplatin and TS-1 for Cancer of unknown primary
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Cancer of unknown primary |
| Date of first enrollment | 2008/07/01 |
| Target sample size | 35 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Carboplatin AUC5 (day1) TS-1 (P.O.) 40 mg/m-2 BID (day1 - 14) max 6 cycles or until PD |
Outcome(s)
| Primary Outcome | Response rate (RECIST criteria) |
|---|---|
| Secondary Outcome | Adverse events (NCI-CTC/AE version 3) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | a) Specific subgroups of CUP (female(adenocarcinoma, Ax LN metastases), female (adenocarcinoma, peritonitis carcinomatosa), squamous cell carcinoma of cervical LN metastases, etc.) b) history of any malignancies c) massive effusion (thorax or abdominal cavity) d) symptomatic brain metastases e) uncontrolled cormobity (DM, hypertension, infection) f) internal use of phenytoine, flucytosyne, or warfarin |
Related Information
| Primary Sponsor | National Cancer Center Hospital, Tokyo |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masashi Ando |
| Address | Japan |
| Telephone | |
| Affiliation | National Cancer Center Hospital, Tokyo Dept of Breast and Oncology |
| scientific contact | |
| Name | Masashi Ando |
| Address | Tskiji 1-1, 5 Cho-me, Chuo-ku, Tokyo, Japan Japan |
| Telephone | 03-3542-2511 |
| Affiliation | National Cancer Center Hospital, Tokyo Dept of Breast and Oncology |