UMIN-CTR Clinical Trial

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

stage III/IV ovarian, tubal and peritoneal carcinomas

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2005

Year

06

Month

07

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Jpn J Clin Oncol, 34:43-45, 2004

Registered date

2005

Year

06

Month

07

Day

Last modified on

2014

Year

02

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000019