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Carboplatin and TS-1 combination chemotherapy in cancer of unknown primary site : a phase II multicenter trial

Carboplatin and TS-1 combination chemotherapy in cancer of unknown primary site : a phase II multicenter trial - CBDCA and TS-1 in CUP Phase II study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023961
Enrollment
35
Registered
2016-09-06
Start date
2008-06-13
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 site

Interventions

carboplatin AUC5, 60 min div day1 TS-1 80mg/m2, twice daily day1-14 until 6 cycles without progression

Sponsors

National Cancer Center Hospital
Lead Sponsor
Tochigi Cancer Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) pathologically diagnosed cancer of unknown primary site b) age over 20 years old c) Performance status (ECOG) 0-2 d) evaluable lesion based on RECIST e) met these criteria within 14 days before registration WBC >=3,000/mm3 or Neutrophil count >=1,500/mm3 hemoglobin >=9.0g/dL Platelet count >=10x104/mm3 T-bil <= 2.0mg/dl AST or ALT <=100IU/L serum Cre <=1.5mg/dL or CCr >=60ml/min(Cockcroft-Gault) f) No prior chemotherapy history g) Informed Consent from patient

Exclusion criteria

Exclusion criteria: a) favorable subset of CUP b) double cancer c) uncontrollable effusion in pleural or abdominal d) uncontrollable brain metastasis e)sever coexisting illness uncontrollable angina, AMI or congestive heart failure within 3 months, uncontrollable diabetes melitus active infection interstitial pneumonitis in CXR severe psychological problems uncontrollable diarrhea physician assessed the patient as ineligible the patients have to continue flucitocin, phenytoin and warfarin pregnant patients

Design outcomes

Primary

MeasureTime frame
overall response rate

Secondary

MeasureTime frame
adverse event, survival outcome(OS, PFS)

Countries

Japan

Contacts

Public ContactEmi Noguchi

National Cancer Center Hospital Department of Breast and Medical Oncology

tshimoi@ncc.go.jp03-3542-2511

Outcome results

None listed

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