Randomized phase II study comparing chemotherapy led by using the classification of primary tumor origin with empirical chemotherapy for patients with unknown primary cancer .

Randomized phase II study comparing chemotherapy led by using the classification of primary tumor origin with empirical chemotherapy for patients with unknown primary cancer . - Randomized phase II study for patients with unknown primary cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001919

Enrollment

120

Registered

2009-04-30

Start date

2008-09-01

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

chemotherapy regimen led by using the classification of the origin of the primary tumor by microarray empirical chemotherapy consisted of carboplatin and paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)histologically or cytologically proven epithelial cancer that is defined by the presence of metastatic disease for which a primary site is undetectable at the time of registration (2)no previous chemotherapy (3)tumor tissue can be obtained before treatment (4)age, more than 20 years old (5)PS 0-2 (6)appropriate organ function (7)written informed consent

Exclusion criteria

Exclusion criteria: (1)cases with the adaptation of radical operation and the radical irradiation (2)Patient subgroups known to have favorable features are excluded. These subgroups include as follows: (a)women with adenocarcinoma involving only axillary lymph nodes (b)women with adenocarcinoma involving the peritoneal cavity (c)patients with squamous cell carcinoma involving only cervical lymph nodes (d)patients with squamous cell carcinoma involving only inguinal lymph nodes (e)patients with poorly differentiated carcinoma consistent with a germ cell tumor or neuroendcrine carcinomas (f)men with osteosclerosis-related bone metastases and elevated PSA in their plasma or tumor (3)active infection or other severe complications (such as gastrointestinal bleeding, heart disease) (4)symptomatic brain tumor (5)interstitial pneumonitis or pulmonary fibrosis (6)patients who underwent bone marrow transplantation (7)patients who underwent peripheral blood stem cell transplantation (8)severe drug allergy (9)alcohol intolerance (10) HBsAg(+) (11)pregnant or lactating women (12)men with the pregnant intention (13)uncontrollable diabetis mellitus

Design outcomes

Primary

Measure	Time frame
one-year survival rate	—

Secondary

Measure	Time frame
overall survival, progression free survival, response rate	—

Countries

Japan

Contacts

Public ContactTakayasu Kurata

Kinki University School of Medicine Department of medical Oncology

t-kurata@med.kindai.ac.jp072-366-0221

Outcome results

None listed

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