UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014822 |
|---|---|
| Receipt number | R000017230 |
| Scientific Title | Multicenter Randomized Phase III Trial of Concurrent Chemoradiotherapy (CCRT) with Cisplatin versus CCRT with Cisplatin and Paclitaxel for Locally Advanced Adenocarcinoma of the Uterine Cervix. |
| Date of disclosure of the study information | 2014/08/11 |
| Last modified on | 2016/02/12 10:06:30 |
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Basic information
Public title
Multicenter Randomized Phase III Trial of Concurrent Chemoradiotherapy (CCRT) with Cisplatin versus CCRT with Cisplatin and Paclitaxel for Locally Advanced Adenocarcinoma of the Uterine Cervix.
Acronym
Randomized Phase III Trial of P-CCRT versus TP-CCRT for Locally Advanced Adenocarcinoma of the Uterine Cervix.
Scientific Title
Multicenter Randomized Phase III Trial of Concurrent Chemoradiotherapy (CCRT) with Cisplatin versus CCRT with Cisplatin and Paclitaxel for Locally Advanced Adenocarcinoma of the Uterine Cervix.
Scientific Title:Acronym
Randomized Phase III Trial of P-CCRT versus TP-CCRT for Locally Advanced Adenocarcinoma of the Uterine Cervix.
Region
| Japan |
Condition
Condition
Locally advanced adenocarcinoma of the uterine cervix
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of CCRT with cisplatin versus CCRT with cisplatin and paclitaxel for patients with locally advanced adenocarcinoma of the uterine cervix (FIGO stage III and IVA).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival (OS)
Key secondary outcomes
Progression-free survival (PFS),Toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Concurrent chemoradiotherapy: CCRT
Cisplatin (40mg/m2, iv, weekly)
Radiothrapy: BED 76.8-77.7Gy10
External beam: whole pelvis 50-50.4Gy/25-28fr, CS after 40-41.4Gy,
HDR-ICBT : 6Gy x 3 (point A)
Interventions/Control_2
Concurrent chemoradiotherapy: CCRT
Cisplatin (30mg/m2, iv, weekly) + Paclitaxel (50mg/m2, iv, weekly)
Radiothrapy: BED 76.8-77.7Gy10
External beam: whole pelvis 50-50.4Gy/25-28fr, CS after 40-41.4Gy,
HDR-ICBT : 6Gy x 3 (point A)
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Pathologically confirmed adenocarcinoma and adenosquamous cell carcinoma of the uterine cervix
2) FIGO StageIIIA, IIIB, IVA
3) Para-aortic lymph nodes=<10mm
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
5) 20 years-old=<age=<70 years-old
6) No prior treatments (radiotherapy, chemotherapy, surgery)
7) Adequate bone marrow, cardiac, pulmonry functions.
- Absolute neutrophil count >= 2,000/mm3
- Hemoglobin >= 10g/dL
- Platelet count >= 100,000/mm3
- Bilirubin =<1.5mg/dL
- AST/ALT =<100 IU/l
- Serum creatinine =<1.2mg/dL
- creatinine clearance >= 50 ml/min
- ECG Normal
8) Written informed consent
Key exclusion criteria
1) Patients with stump cancer
2) Patients with active infections
3) Patients with hydronephrosis
4) Patients with unstable angina, history of cardiac infarction within 6 months, or arrhythmia that requires medical treatment
5) Patients with serious complications(cardiac disease,uncontrolled diabetes mellitus,malignant hypertension,hemorrhagic tendancy)
6) Patients who previously received pelvic radiotherapy
7) Patients with active concomitant malignancy
8) Patients who have undergone surgical staging
9) Patients with serious drug hypersensitivity
10) Patients with positive HBsAg
11) Patients during pregnancy or breast-feeding, or unwilling to the use of contraception
12) Patients who judged inappropriate for this study by the treating physician
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Nagai, M.D., Ph.D. |
Organization
University of the Ryukyus
Division name
Department of Obsterics and gynecology, Graduate School of Medical Science
Zip code
Address
207 Uehara, Nishinhara-cho, Nakagami-gun, Okinawa, 903-0215, Japan
TEL
098-895-3331
jgog1074@jgog.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Nagai, M.D., Ph.D./ Takafumi Toita, M.D., Ph.D. |
Organization
JGOG1074 Coordinating Office
Division name
Department of Obsterics and Gynecology, Graduate School of Medical Science, University of the Ryukyu
Zip code
Address
207 Uehara, Nishinhara-cho, Nakagami-cho, Okinawa, 903-0215, Japan
TEL
098-895-3331
Homepage URL
http://www.jgog.gr.jp/
jgog1074@jgog.gr.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
琉球大学病院(沖縄県),長崎大学病院(長崎県),四国がんセンター(愛媛県),県立広島病院(広島県),愛媛大学病院(愛媛県),佐賀大学病院(佐賀県),徳島大学病院(徳島県),茨城県立中央病院(茨城県),九州がんセンター(福岡県),東北大学病院(宮城県),沖縄県立中部病院(沖縄県),九州大学病院(福岡県),大阪市立大学病院(大阪府),香川県立中央病院(香川県),横浜市立大学病院(神奈川県),自治医科大学病院(栃木県),新潟大学病院(新潟県),三重大学病院(三重県),奈良県立医科大学病院(奈良県),神戸市立医療センター(兵庫県),長崎みなとメディカルセンター(長崎県),伊勢赤十字病院(三重県),奈良県総合医療センター(奈良県),埼玉医科大学国際医療センター(埼玉県),慶応義塾大学病院(東京都),大阪府立成人病センター(大阪府),東海大学病院(神奈川県),千葉大学病院(千葉県),大阪医科大学病院(大阪府),熊本大学病院(熊本県),京都市立病院(京都府),厚生連札幌厚生病院(北海道),岩手医科大学病院(岩手県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 11 | Day |
Last modified on
| 2016 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017230
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