UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001541 |
|---|---|
| Receipt number | 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 12:13:05 |
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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
| Obstetrics 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
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
mshima12@med.tottori-u.ac.jp
Sponsor or person
Institute
Japan ovarian mucinous adenocarcinoma study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001865
