Phase III Trial of Stage I Ovarian Cancer After Surgery
NCT ID: NCT04063527
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2012-07-20
2030-02-01
Brief Summary
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Detailed Description
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1. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types
2. Facility where a subject is enrolled
3. International Federation of Gynecology and Obstetrics(FIGO) clinical staging: Stage Ia/ Ib vs. Stage Ic(b)
Group A: adjuvant chemotherapy group (standard treatment group):
While one of the following treatments will be performed, the number of cycles is entrusted to the treatment policy of each facility.
Paclitaxel plus Carboplatin (TC) therapy; Paclitaxel (PTX) 175 mg/m2 + Carboplatin(CBDCA) area under curve(AUC) 6 q3weeks day1, 3 to 6 cycles Docetaxel plus Carboplatin (DC) therapy; Docetaxel(DTX) 70 mg/m2 + CBDCA AUC 6 q3weeks day1, 3 to 6 cycles
After the start of TC therapy, switching from PTX to DTX due to an adverse event is permitted.
Group B: observation group (study treatment group): Observation only, no adjuvant chemotherapy administered.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard therapy
combination of paclitaxel and carboplatin
adjuvant chemotherapy
combination of paclitaxel and carboplatin
Observation
Observation
No interventions assigned to this group
Interventions
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adjuvant chemotherapy
combination of paclitaxel and carboplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) and Ic(b)(all degree of differentiation and all histologic type)
3. Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
4. Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum (\[Peritoneal biopsy\] see details below), retroperitoneal lymph node dissection (see details below \[Retroperitoneal lymph node dissection\]).
However, for the following cases, it is eligible as a condition to record on the official document.
* Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed.
* Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached.
5. Age: 20 or older
6. Performance status (PS):0-1
7. Case with initial therapy for postoperative primary lesion
8. Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
9. Reasonable organ function
10. Patient must have signed informed consent.
Exclusion Criteria
2. Patients containing sarcoma elements
3. Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT
4. Patients with serious complications
5. Patients with active infection
6. Patients with intestinal paralysis or intestinal obstruction
7. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
8. Patients with previous chemotherapy or radiation therapy
9. Patients with serious drug hypersensitivity
10. Patients with peripheral motor/sensory neuropathy \[grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0\]
11. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
12. Patients with positive HBsAg. Patients with more than 2.1 log/copies ml based on fixed Hepatitis B virus (HBV)-DNA who are positive with either antigen-positive Hepatitis B (HBs), anti-hepatitis B core antigen or anti-hepatitis B surface antigen.
13. Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
20 Years
FEMALE
No
Sponsors
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Korean Gynecologic Oncology Group
OTHER
Japanese Gynecologic Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Hiroshi Tanabe, M.D.
Role: STUDY_CHAIR
National Cancer Center Hospital East
Locations
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Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan
Tosei General Hospital
Seto-shi, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, Japan
The Jikei University School of Medicine Kashiwa Hospital
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Ehime University Hospital
Onsen-gun, Ehime, Japan
Kyusyu Medical Center
Fukuoka, Fukuoka, Japan
Kyusyu Cancer Center
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, Japan
JA Hiroshima General Hospital
Hatsukaichi-shi, Hiroshima, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, Japan
Miyoshi Central Hospital
Miyoshi-shi, Hiroshima, Japan
Hospital Hakodate Hokkaido
Hakodate-shi, Hokkaido, Japan
JA Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospita
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan
Kansai Rosai Hospital
Amagasaki-shi, Hyōgo, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyōgo, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Kagoshima University Medical And Dental Hospital
Kagoshima, Kagoshima-ken, Japan
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
St.Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Yokohama Minami Kyosai Hospital
Yokohama, Kanagawa, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kobe City Medical Center General Hospital
Kobe, Kobe, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, Kyoto, Japan
Ise Red Cross Hospital
Ise-shi, Mie-ken, Japan
JA Matsuzaka Central Hospital
Matsuzaka, Mie-ken, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Shinshu University Hospital
Matsumoto-shi, Nagano, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Aichi Cancer Center
Nagoya, Nagoya, Japan
Nara Prefecture General Medical Center
Nara, Nara, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Oita University Hospital
Yufu, Oita Prefecture, Japan
Hospital University of the Ryukyus
Nakagami-gun, Okinawa, Japan
Tomishiro Central Hospital
Tomishiro-shi, Okinawa, Japan
Okinawa Prefectural Chubu Hospital
Uruma, Okinawa, Japan
Kaizuka City Hospital
Kaizuka, Osaka, Japan
Osaka International Cancer Center
Osaka, Osaka, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
Kindai University Hospital
Ōsaka-sayama-shi, Osaka, Japan
Sakai City Medical Center
Sakai, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Osaka Medical College Hospital
Takatsuki-shi, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Koshigaya Municipal Hospital
Koshigaya-shi, Saitama, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, Japan
Saitama Cancer Center
Shinden, Saitama, Japan
National Defense Medical College Hospital
Tokorozawa-shi, Saitama, Japan
Saitama National Hospital
Wako, Saitama, Japan
Sapporo Medical University Hospital
Sapporo, Sapporo, Japan
Shikoku Cancer Center
Matsuyama, Shikoku, Japan
Shimane University Hospital
Izumo, Shimane, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, Japan
Japanese Red Cross Shizuoka Hospital
Shizuoka, Shizuoka, Japan
Dokkyo Medical University Hospital
Mibu, Tochgi, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
Tokushima University Hospital
Tokushima, Tokushima, Japan
Tokyo Women's Medical University Medical Center East
Arakawa City, Tokyo, Japan
Tokyo Medical And Dental University University Hospital of Medicine
Bunkyō-Ku, Tokyo, Japan
Nippon Medical School Hospital
Bunkyō-Ku, Tokyo, Japan
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
Sasaki Faundation Kyoundo Hospital
Chiyoda City, Tokyo, Japan
Tokyo Metropolitan Tama Medical Center
Fuchu-shi, Tokyo, Japan
The Jikei University Katsushika Medical Center
Katsushika-ku, Tokyo, Japan
The Jikei University Daisan Hospital
Komae-shi, Tokyo, Japan
The Cancer Institute Hospital
Koto-Ku, Tokyo, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan
The Jikei University Hospital
Minato-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
Kosei General Hospital
Suginami, Tokyo, Japan
Tachikawa Hospital
Tachikawa-shi, Tokyo, Japan
Tottori Prefectural Central Hospital
Tottori-shi, Tottori, Japan
Tottori University Hospital
Yonago-shi, Tottori, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Tokuyama Central Hospital
Shunan-shi, Yamaguchi, Japan
Yamaguchi Red Cross Hospital
Yamaguchi, Yamaguchi, Japan
Nagano Municipal Hospital
Nagano, , Japan
Saiseikai Nagasaki Hospital
Nagasaki, , Japan
Saga University Hospital
Saga, , Japan
Jichi Medical University Saitama Medical Center
Saitama, , Japan
National Cancer Center
Ilsandong, Goyang, South Korea
Gachon University Gil Medical Center
Namdong, Incheon, South Korea
Seoul ST' Mary's Hospital
Seocho, Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Taiki Ueno
Role: primary
Hidekazu Asai
Role: primary
Takuma Fujii
Role: primary
Yoshihito Yokoyama
Role: primary
Hirokuni Takano
Role: primary
Hiroshi Tanabe
Role: primary
Takashi Matsumoto
Role: primary
Yasuyuki Hasuo
Role: primary
Masao Okadome
Role: primary
Kiyoko Kato
Role: primary
Kimio Ushijima
Role: primary
Kenichiro Morishige
Role: primary
Takashi Hirakawa
Role: primary
Kazuto Nakamura
Role: primary
Yoshinobu Nakanishi
Role: primary
Junichi Kodama
Role: primary
Yuko Shiroyama
Role: primary
Takefumi Akagi
Role: primary
Tsuyoshi Yamashita
Role: primary
Tsunemaro Kojo
Role: primary
Hidemichi Watari
Role: primary
Satoshi Yamaguchi
Role: primary
Kensuke Hori
Role: primary
Yasushi Mizutani
Role: primary
Toyomi Sato
Role: primary
Tsukasa Baba
Role: primary
Hiroaki Kobayashi
Role: primary
Toshiaki Nakamura
Role: primary
Takeshi Hirasawa
Role: primary
Nao Suzuki
Role: primary
Takashi Onda
Role: primary
Naho Yokota
Role: primary
Reiko Numazaki
Role: primary
Hiroyuki Shigeta
Role: primary
Hisamori Kato
Role: primary
Shinya Yoshioka
Role: primary
Hidetaka Katabuchi
Role: primary
Tomoharu Okubo
Role: primary
Takaharu Yamawaki
Role: primary
Tsukio Deguchi
Role: primary
Eiji Kondo
Role: primary
Hideki Tokunaga
Role: primary
Tsutomu Miyamoto
Role: primary
Kiyonori Miura
Role: primary
Masahiko Mori
Role: primary
Tsunekazu Kita
Role: primary
Takayuki Enomoto
Role: primary
Akira Kikuchi
Role: primary
Shinpei Sato
Role: primary
Yoichi Aoki
Role: primary
Toshiyuki Maehama
Role: primary
Yoshiyuki Takahashi
Role: primary
Takeshi Yokoi
Role: primary
Shoji Kamiura
Role: primary
Toshiyuki Sumi
Role: primary
Noriomi Matsumura
Role: primary
Toshiya Yamamoto
Role: primary
Tadashi Kimura
Role: primary
Masahide Omichi
Role: primary
Keiichi Fujiwara
Role: primary
[email protected]
Role: backup
Shin Suga
Role: primary
Yoshinobu Hamada
Role: primary
Harushige Yokota
Role: primary
Masashi Takano
Role: primary
Hiroyuki Nakagawa
Role: primary
Tsuyoshi Saito
Role: primary
Kazuhiro Takehara
Role: primary
Satoru Kyo
Role: primary
Yasuyuki Hirashima
Role: primary
Yoshikazu Ichikawa
Role: primary
Ichio Fukasawa
Role: primary
Hiroyuki Fujiwara
Role: primary
Minoru Irahara
Role: primary
Hiroaki Nagano
Role: primary
Kimio Wakana
Role: primary
Keisuke Kurose
Role: primary
Katsutoshi Oda
Role: primary
Toshiharu Yasugi
Role: primary
Masaru Sakamoto
Role: primary
Akira Koyama
Role: primary
Shigeki Niimi
Role: primary
Kyosuke Yamada
Role: primary
Kazuyoshi Kato
Role: primary
Kyoko Tanaka
Role: primary
Aikou Okamoto
Role: primary
Daisuke Aoki
Role: primary
Tsutomu Tabata
Role: primary
Eizo Kimura
Role: primary
Nobumaru Hirao
Role: primary
Yukihisa Minagawa
Role: primary
Tetsuro Oishi
Role: primary
Satoru Nagase
Role: primary
Kei Hirabayashi
Role: primary
Yasunobu Kanamori
Role: primary
Atsushi Mori
Role: primary
Akira Fujishita
Role: primary
Masatoshi Yokoyama
Role: primary
Ryo Konno
Role: primary
Sang Yoon Park
Role: primary
Lee Kwang Beom
Role: primary
KEUN HO LEE
Role: primary
Song Tae Jong
Role: primary
Jung-Yun Lee
Role: primary
Other Identifiers
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JGOG3020
Identifier Type: -
Identifier Source: org_study_id