UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019191 |
|---|---|
| Receipt number | R000021559 |
| Scientific Title | Randomized Phase II/III Trial of Conventional Paclitaxel and Carboplatin with/without Bevacizumab versus Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma (JCOG1311, CC-TC/ddTC-P2/3) |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2021/01/05 16:08:13 |
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Basic information
Public title
Randomized Phase II/III Trial of Conventional Paclitaxel and Carboplatin with/without Bevacizumab versus Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma (JCOG1311, CC-TC/ddTC-P2/3)
Acronym
Randomized Phase II/III Trial of Conventional Paclitaxel and Carboplatin with/without Bevacizumab versus Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma (JCOG1311, CC-TC/ddTC-P2/3)
Scientific Title
Randomized Phase II/III Trial of Conventional Paclitaxel and Carboplatin with/without Bevacizumab versus Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma (JCOG1311, CC-TC/ddTC-P2/3)
Scientific Title:Acronym
Randomized Phase II/III Trial of Conventional Paclitaxel and Carboplatin with/without Bevacizumab versus Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma (JCOG1311, CC-TC/ddTC-P2/3)
Region
| Japan |
Condition
Condition
Metastatic or Recurrent Cervical Carcinoma, not amenable to curative surgery or radiotherapy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical benefits of Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab compared with Conventional Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
Phase II: Response Rate (Assessed in the following timing:
i) day 15-21 in the 3rd course, ii) day 15-21 in the 6th course, iii) day 22-56 in the last course (day 1 denotes the initial date of each course)),
Phase III: Overall Survival
Key secondary outcomes
Phase II: Adverse Events, Serious Adverse Events
Phase III: Progression-free Survival, Response Rate, Adverse Events, Serious Adverse Events, Proportion of periods of non-hospitalization to those of the planned treatment during the first 6 courses
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 / Carboplatin with/without Bevacizumab (Paclitaxel 175 mg/m2 day1, Carboplatin AUC5 day1, Bevacizumab 15 mg/kg day1, repeated every 3 weeks for 6 cycles. Protocol treatment (Paclitaxel / Carboplatin) is to be extended to up to 9 cycles when a certain tumor response is observed. Bevacizumab is to be administerd following tumor response and criteria for discontinuing.)
Interventions/Control_2
B: Chemotherapy: Dose-dense Paclitaxel / Carboplatin with/without Bevacizumab (Paclitaxel 80 mg/m2 day1, 8, 15 Carboplatin AUC5 day1, Bevacizumab 15 mg/kg day1, repeated every 3 weeks for 6 cycles. Protocol treatment (Paclitaxel / Carboplatin) is to be extended to up to 9 cycles when a certain tumor response is observed. Bevacizumab is to be administerd following tumor response and criteria for discontinuing.)
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) Uterine cervical cancer histologically proven by biopsy to the primary tumor
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 treatments for the first relapse
4) 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 either of paraaortic or inguinal LN has been irradiated
3. All lesions are localized inside the pelvic cavity, and some of them have been irradiated
5) No prior treatment of the followings was done,
1. prior surgical therapy for relapse inside the pelvic cavity with resection of bladder or intestinal tract
2. prior chemoradiation twice or more
3. prior adjuvant chemotherapy for initial treatment including two or more regimens
4. prior chemotherapy for metastatic or relapse regions
5. progression during prior neoadjuvant chemotherapy of taxane-platinum regimen
6. relapse or progression within 24 weeks after adjuvant chemotherapy of taxane-platinum regimen
6) Certain interval from the last administration of previous treatments as the followings
1. 42 days or more after prior chemoradiation
2. 21 days or more after prior radiatin
3. 28 days or more after prior surgical treatment
4. 14 days or more after prior adjuvant chemoterapy
7) Age: 20 to 75 years
8) PS: 0-2
9) No bilateral hydronephrosis
10) Peripheral motor neuropathy <= Grade 1, Peripheral sensory neuropathy <= Grade 1
11) Sufficient organ functions with the latest laboratory examination within 14 days
12) Normal ECG
13) Written informed consent
Key exclusion criteria
(1) Simultaneous or metachronous (within 5 years) double cancers.
(2) Active systemic infections to be treated.
(3) Body temperature of 38 or more degrees Celsius
(4) Women during pregnancy, possible pregnancy, or breast-feeding
(5) Psychiatric disease
(6) Continuous systemic steroid treatment
(7) Uncontrolled diabetes mellitus or routine administration of insulin
(8) Uncontrolled hypertension
(9) Unstable angina or prior myocardial infarction with in 6 months
(10) Metastasis to central nerve system with a symptom
(11) Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
(12) HBs antigen positive, HCV antibody positive, HIV antibody positive
(13) hypersensitivity to polyoxyethylated castor oil
(14) hypersensitivity to alcohol
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Yaegashi |
Organization
Tohoku University, School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-1 Seiryou Chou, Aoba-Ku, Sendai-City, Miyagi Prefecture, Japan
TEL
022-717-7251
yaegashi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuya Ishikawa |
Organization
JCOG1311 Coordinating Office
Division name
Division of Gynecology, National Cancer Center Hospital
Zip code
Address
5-1-1 Tsukuji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511(7847)
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
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
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）
岩手医科大学（岩手県）
東北大学病院（宮城県）
筑波大学臨床医学系（茨城県）
茨城県立中央病院・茨城県地域がんセンター（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）
埼玉医科大学総合医療センター（埼玉県）
千葉大学医学部（千葉県）
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）
がん・感染症センター都立駒込病院（東京都）
東京女子医科大学（東京都）
慶應義塾大学病院（東京都）
東京慈恵会医科大学附属病院（東京都）
がん研究会有明病院（東京都）
東京大学医学部（東京都）
順天堂大学医学部附属順天堂医院（東京都）
NTT東日本関東病院（東京都）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
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）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
名古屋大学医学部（愛知県）
京都大学医学部附属病院（京都府）
大阪市立大学医学部附属病院（大阪府）
大阪国際がんセンター（大阪府）
大阪市立総合医療センター（大阪府）
大阪医科大学（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）
愛媛大学医学部附属病院（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）
熊本大学医学部（熊本県）
鹿児島大学病院（鹿児島県）
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
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021559
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| Registered date | File name |
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