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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000335
Receipt No. R000000425
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)
Date of disclosure of the study information 2006/02/21
Last modified on 2015/04/14

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Basic information
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
Condition uterine cervical neoplasms
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Institutions
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)

Other administrative information
Date of disclosure of the study information
2006 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2006 Year 02 Month 21 Day
Last modified on
2015 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000425

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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