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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001541
Receipt No. R000001865
Scientific Title Phase II trial of combination chemotherapy consisting of S-1 and Oxaliplatin in patients with advanced or recurrent mucinous adenocarcinoma of the ovary
Date of disclosure of the study information 2009/01/01
Last modified on 2014/05/02

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Basic information
Public title Phase II trial of combination chemotherapy consisting of S-1 and Oxaliplatin in patients with advanced or recurrent mucinous adenocarcinoma of the ovary
Acronym MOST trial
Scientific Title Phase II trial of combination chemotherapy consisting of S-1 and Oxaliplatin in patients with advanced or recurrent mucinous adenocarcinoma of the ovary
Scientific Title:Acronym MOST trial
Region
Japan

Condition
Condition Mucinous adenocarcinoma of the ovary including metastatic ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety for combination chemotherapy consisting of S-1 and Oxaliplatin in patients with advanced or recurrent mucinous adenocarcinoma of the ovary with measurable lesions, including metastatic ovarian cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes The incidence of adverse event Progression free survival Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination chemotherapy consisting of S-1+ Oxaliplatin (SOX)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Patients with advanced (FIGO III-IV stage) or recurrent mucinous adenocarcinoma of the ovary with measurable lesions, including metastatic ovarian cancer
2.Performance status: 0-2
3.Age: 20 years and more than 20 years old
4.Patients who received no previous chemotherapy, or only one regimen not including TS-1 nor oxaliplatin. Treatment-free interval must be more than 4 weeks in patients with previous chemotherapy.
5.Patients possible to have tablet agent.
6.Patients without severe dysfunction of major organs
7.Patients possible to be alive over 3 months after treatment
8.Signed informed consent must be obtained
Key exclusion 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junzo Kigawa
Organization Tottori University Hospital
Division name Cancer Center
Zip code
Address Nishimachi 36-1, Yonago, Japan
TEL 0859-38-6292
Email mshima12@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Muneaki Shimada
Organization Faculty of Medicine, Tottori University
Division name Department of Obstetrics and Gynecology
Zip code
Address Nishimachi 36-1, Yonago, Japan
TEL 0859-38-6647
Homepage URL
Email mshima12@med.tottori-u.ac.jp

Sponsor
Institute Japan ovarian mucinous adenocarcinoma study group
Institute
Department

Funding Source
Organization Gynecological Tumor Support Organization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 02 Day
Last modified on
2014 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001865

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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