UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000335 |
|---|---|
| Receipt number | 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 12:33:52 |
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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
| Obstetrics 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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000425
