Phase II trial of combination chemotherapy consisting of S-1 and Oxaliplatin in patients with advanced or recurrent mucinous adenocarcinoma of the ovary

UMIN ID: UMIN000001541

Registered date:01/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Mucinous adenocarcinoma of the ovary including metastatic ovarian cancer
• Date of first enrollment: 2008/08/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Combination chemotherapy consisting of S-1+ Oxaliplatin (SOX)

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: The incidence of adverse event Progression free survival Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1.Patients having fever over 38.0 2.Patients with infection or more than WBC:12,000/mm3 3.Patients with severe complications 4.Patients with double cancer 5.Patients with massive pleural effusion, ascites and pericardial fluid need to continuous drainage 6.Patients with severe paresthesia with functional disorder, or dysesthesia 7.Patients who cannot undergo treatment due to the past history of mental disorder or the central nerve disorder 8.Patients with brain metastasis 9.Patients with more than grade 3 diarrhea. More than grade 2 diarrhea in patients receiving colostomy.

Related Information

• Primary Sponsor: Japan ovarian mucinous adenocarcinoma study group
• Source(s) of Monetary Support: Gynecological Tumor Support Organization