UMIN-CTR Clinical Trial

Public title

A Randomized Phase III trial of Paclitaxel plus Cisplatin versus Paclitaxel plus Carboplatin in Stage IVB, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

Acronym

A Randomized Phase III trial of Paclitaxel plus Cisplatin versus Paclitaxel plus Carboplatin in Stage IVB, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

Scientific Title

A Randomized Phase III trial of Paclitaxel plus Cisplatin versus Paclitaxel plus Carboplatin in Stage IVB, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

Scientific Title:Acronym

A Randomized Phase III trial of Paclitaxel plus Cisplatin versus Paclitaxel plus Carboplatin in Stage IVB, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

Region

Japan

Condition

uterine cervical neoplasms

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVB, Persistent, or Recurrent Cervical Cancer

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

overall survival

Key secondary outcomes

progression-free survival, response rate, adverse events, severe adverse events, proportion of periods of non-hospitalization to those of the planned treatment

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: chemotherapy:Paclitaxel/Cisplatin

Interventions/Control_2

B: chemotherapy:Paclitaxel/Carboplatin

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

1) histologically proven uterine cervical cancer
2) squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
3) one of the followings,
1.primary stage IVb cervical cancer
2.the first relapse or persistent cervical cancer after curative first line treatments
3.the second relapse or persistent cervical cancer after curative second line treatmets including radiation, systemic chemotherapy, hormonal therapy, or vaccination therapy for the first relapse
4) Patients may have been previously treated with less than 50 Gy of palliative radiation therapy
5) Patients have received no prior treatment or a certain interval must have elapsed from the last administration of previous treatments including palliative radiatinon therapy
6) one of the followings,
1.There is at least one metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN
2.There is no metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN and some of the lesions have been irradiated
3.All lesions are localized inside the pelvic cavity, and some of them have been irradiated
7) no prior surgical therapy for metastatic lesions of the lung or inside the pelvic cavity
8) no bilateral hydronephrosis
9) no prior chemotherapy including more than two platinium-containing regimens
10) no prior chemotherapy including taxane
11) age: 20 to75 years
12) PS: 0-2
13) ANC >=1,500 /mm3, Plt>=10.0 X 104/mm3, T-bil<=1.5 mg/dl, GOT(AST)<=100IU/l, sCre <=1.2 mg/dl, Ccr>=50ml/min in using the Cockcroft-Gault equation, and normal ECG
14) written informed consent

Key exclusion criteria

1) patients who have some neurologically functional disorder
2) symptomatic CNS metastasis
3) hypersensitive to alcohol
4) active infection
5) HBs antigen positive
6) uncontrollable hypertension
7) history of myocardiac infarction within six months
8) unstable angina
9) uncontrollable diabetes
10) Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years
11) women during pregnancy or breast-feeding
12) patients with psychiatric liiness
13) patients who have been treated with the systemic steroids medication

Target sample size

250

Name of lead principal investigator

1st name
Middle name
Last name	Toshiharu Kamura

Organization

Kurume University School of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code

Address

67 Asahi-machi, Kurume 830-0011, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Ryo Kitagawa

Organization

JCOG0505 Coordinating Office

Division name

Kanto Medical Center, NTT EC

Zip code

Address

5-9-2 Higashi-gotanda, Shinagawa-ku, Tokyo, 141-0022, Japan

TEL

03-3448-6111

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院（北海道）
札幌医科大学（北海道）
東北大学病院（宮城県）
筑波大学臨床医学系（茨城県）
防衛医科大学校（埼玉県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学総合医療センター（埼玉県）
東京慈恵会医科大学附属柏病院（千葉県）
国立がん研究センター中央病院（東京都）
東京慈恵会医科大学附属病院（東京都）
癌研究会有明病院（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）
新潟県立がんセンター新潟病院（新潟県）
信州大学医学部（長野県）
愛知県がんセンター中央病院（愛知県）
大阪市立大学医学部附属病院（大阪府）
近畿大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
大阪市立総合医療センター（大阪府）
近畿大学医学部堺病院（大阪府）
兵庫県立がんセンター（兵庫県）
鳥取大学医学部（鳥取県）
国立病院機構呉医療センター・中国がんセンター（広島県）
国立病院機構四国がんセンター（愛媛県）
国立病院機構九州がんセンター（福岡県）
久留米大学医学部（福岡県）
九州大学病院（福岡県）
佐賀大学医学部（佐賀県）
鹿児島市立病院（鹿児島県）
琉球大学医学部（沖縄県）

Date of disclosure of the study information

2006

Year

02

Month

21

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25732161

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

2006

Year

01

Month

12

Day

Date of IRB

Anticipated trial start date

2006

Year

02

Month

01

Day

Last follow-up date

2011

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2006

Year

02

Month

21

Day

Last modified on

2015

Year

04

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000425