Phase II study in combination with Carboplatin and TS-1 for Cancer of unknown primary

Phase II study in combination with Carboplatin and TS-1 for Cancer of unknown primary - CBDCA/TS-1 for CUP

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001236

Enrollment

Registered

2008-08-01

Start date

2008-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of unknown primary

Interventions

Carboplatin AUC5 (day1) TS-1 (P.O.) 40 mg/m-2 BID (day1 - 14) max 6 cycles or until PD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Cancer of unknown primary (histologically proven carcinoma, primary site was not detected by systemic survey) b) Age >= 20 yrs c) Performance status (ECOG) 0-2 d) Mesurable lesion by the RECIST criteria e) Adequate organ functions f) no prior chemotherapy for CUP g) written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Response rate (RECIST criteria)	—

Secondary

Measure	Time frame
Adverse events (NCI-CTC/AE version 3)	—

Countries

Japan

Contacts

Public ContactMasashi Ando

National Cancer Center Hospital, Tokyo Dept of Breast and Oncology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026