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 |
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.
Randomized Phase III Trial of P-CCRT versus TP-CCRT for Locally Advanced Adenocarcinoma of the Uterine Cervix.
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.
Randomized Phase III Trial of P-CCRT versus TP-CCRT for Locally Advanced Adenocarcinoma of the Uterine Cervix.
Japan |
Locally advanced adenocarcinoma of the uterine cervix
Obstetrics and Gynecology |
Malignancy
NO
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).
Safety,Efficacy
Phase III
Overall survival (OS)
Progression-free survival (PFS),Toxicity
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine | Other |
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)
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)
20 | years-old | <= |
70 | years-old | >= |
Female
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
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
240
1st name | |
Middle name | |
Last name | Yutaka Nagai, M.D., Ph.D. |
University of the Ryukyus
Department of Obsterics and gynecology, Graduate School of Medical Science
207 Uehara, Nishinhara-cho, Nakagami-gun, Okinawa, 903-0215, Japan
098-895-3331
jgog1074@jgog.gr.jp
1st name | |
Middle name | |
Last name | Yutaka Nagai, M.D., Ph.D./ Takafumi Toita, M.D., Ph.D. |
JGOG1074 Coordinating Office
Department of Obsterics and Gynecology, Graduate School of Medical Science, University of the Ryukyu
207 Uehara, Nishinhara-cho, Nakagami-cho, Okinawa, 903-0215, Japan
098-895-3331
http://www.jgog.gr.jp/
jgog1074@jgog.gr.jp
Japanese Gynecologic Oncology Group
Japanese Gynecologic Oncology Group
Non profit foundation
NO
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)
2014 | Year | 08 | Month | 11 | Day |
Unpublished
Terminated
2014 | Year | 06 | Month | 02 | Day |
2014 | Year | 07 | Month | 01 | Day |
2022 | Year | 07 | Month | 01 | Day |
2022 | Year | 08 | Month | 01 | Day |
2022 | Year | 11 | Month | 01 | Day |
2023 | Year | 02 | Month | 01 | Day |
2014 | Year | 08 | Month | 11 | Day |
2016 | Year | 02 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017230
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |