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

UMIN ID: UMIN000001919

Registered date:30/04/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: cancer of unknown primary
• Date of first enrollment: 2008/09/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: one-year survival rate
• Secondary Outcome: overall survival, progression free survival, response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Ministry of Health, Labour and Welfare scientific research Nakagawa squad
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare