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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000005
Receipt No. R000000019
Scientific Title Feasibility study of neoadjuvant chemotherapy followed by interval cytoreductive surgery for stage III/IV ovarian, tubal and peritoneal cancers.(JCOG0206, OVCA-NAC-P2)
Date of disclosure of the study information 2005/06/07
Last modified on 2014/02/21

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Basic information
Public title Feasibility study of neoadjuvant chemotherapy followed by interval cytoreductive surgery for stage III/IV ovarian, tubal and peritoneal cancers.(JCOG0206, OVCA-NAC-P2)
Acronym Feasibility study of neoadjuvant chemotherapy followed by interval cytoreductive surgery for stage III/IV ovarian, tubal and peritoneal cancers.(JCOG0206, OVCA-NAC-P2)
Scientific Title Feasibility study of neoadjuvant chemotherapy followed by interval cytoreductive surgery for stage III/IV ovarian, tubal and peritoneal cancers.(JCOG0206, OVCA-NAC-P2)
Scientific Title:Acronym Feasibility study of neoadjuvant chemotherapy followed by interval cytoreductive surgery for stage III/IV ovarian, tubal and peritoneal cancers.(JCOG0206, OVCA-NAC-P2)
Region
Japan

Condition
Condition stage III/IV ovarian, tubal and peritoneal carcinomas
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purposes are to assess the safety and efficacy of the treatment starting with NAC with paclitaxel and CBDCA for phase III study comparing NAC therapy with current standard procedure, and to know whether we can accurately diagnose these advanced carcinomas by imaging studies, cytologic findings, and tumor makers without staging laparotomy or laparoscopy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes proportion of clinical complete remission
Key secondary outcomes 1) positive predictive value (PPV) of prelaparoscopic diagnosis concerning the origin and histology; proportion of the patients diagnosed as müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
2) PPV of prelaparoscopic diagnosis concerning clinical stage; proportion of the patients diagnosed as stage III or IV by laparoscopic inspection among those diagnosed by prelaparoscopic findings
3) PPV of overall prelaparoscopic diagnosis; proportion of the patients diagnosed as stage III or IV müllerian carcinoma by laparoscopic inspection and histopathology of biopsy specimen among those diagnosed by prelaparoscopic findings
4) response rate to NAC among patients whose clinical diagnosis is confirmed by laparoscopy
5) proportion of patients who received ICS among patients whose clinical diagnosis is confirmed by laparoscopy
6) progression-free survival among patients whose clinical diagnosis is confirmed by laparoscopy
7) operative morbidity among all enrolled patients
8) adverse events among all enrolled patients
9) overall survival among all enrolled patients

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 Maneuver
Interventions/Control_1 Diagnostic laparoscopy, Interval Cytoreductive Surgery(ICS),
Neoadjuvant and Post-surgical chemotherapy (Paclitaxel and Carboplatin)
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
75 years-old >=
Gender Female
Key inclusion criteria stage III or IV müllerian carcinoma by prelaparoscopic clinical findings including imaging studies (CT, MRI or ultrasonography)
and cytology of ascites, pleural effusions, or fluids obtained by tumor centesis
-CA125>200U/ml and CEA<20ng/ml.
-clinically deemed to be a candidate for debulking surgery without evidence of brain, bone, bone marrow metastases, multiple lung, or multiple liver metastases
-presence of at least one measurable lesion
-previously untreated for these malignancies and no history of treatment with chemotherapy nor radiotherapy even for other diseases
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3,
-adequate bone marrow, hepatic, renal, cardiac and respiratory functions
-written informed consent
Key exclusion criteria -synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
-pregnant or nursing
-severe mental disorders
-systemic and continuous use of steroidal drugs
-active infections
-uncontrolled hypertension
-diabetes mellitus, uncontrolled or controlled with insulin
-history of cardiac failure, unstable angina, myocardial infarction within 6 months prior to the registration
-liver cirrhosis or bleeding tendency contraindicating debulking surgery
-intestinal occlusion necessary for surgical treatment
-hypersensitivity to alcohol
Target sample size 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Yoshikawa, MD
Organization University of Tsukuba
Division name Department of Obstetrics and Gynecology, Institute of Clinical Medicine
Zip code
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8575, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Onda, MD
Organization JCOG0206 Coordinating office
Division name Division of Gynecologic Oncology, National Cancer Center Hospital
Zip code
Address 5-1-1 Tsukiji,Chuo-ku,Tokyo,104-0045,JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00112086
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 札幌医科大学(北海道)
東北大学医学部(宮城県)
筑波大学臨床医学系(茨城県)
群馬県立がんセンター(群馬県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
東京慈恵会医科大学附属柏病院(千葉県)
国立がんセンター中央病院(東京都)
東京慈恵会医科大学(東京都)
癌研究会癌研究所附属病院(東京都)
東京大学医学部(東京都)
順天堂大学医学部(東京都)
北里大学医学部(神奈川県)
長岡赤十字病院(新潟県)
愛知県がんセンター(愛知県)
国立名古屋病院(愛知県)
近畿大学医学部(兵庫県)
島根医科大学医学部(島根県)
川崎医科大学(岡山県)
国立呉病院(広島県)
国立病院四国がんセンター(愛媛県)
国立病院九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学医学部(福岡県)
佐賀医科大学(佐賀県)
鹿児島市立病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2005 Year 06 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/19181369
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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
2002 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2003 Year 03 Month 01 Day
Last follow-up date
2007 Year 02 Month 01 Day
Date of closure to data entry
2007 Year 08 Month 01 Day
Date trial data considered complete
2007 Year 08 Month 01 Day
Date analysis concluded
2007 Year 08 Month 01 Day

Other
Other related information Jpn J Clin Oncol, 34:43-45, 2004

Management information
Registered date
2005 Year 06 Month 07 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000019

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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