Epithelial Ovarian CancerPhase 3NCT04063527
Phase III Trial of Stage I Ovarian Cancer After Surgery
A Phase 3 study testing adjuvant chemotherapy in people with Epithelial Ovarian Cancer, run by Japanese Gynecologic Oncology Group at 103 sites in 2 countries.
Trial summary
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- adjuvant chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 103 sitesin 2 countries
- Study dates
- 20 Jul 2012to 1 Feb 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of histopathologically epithelial ovarian cancer
- 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)
- Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
- 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.
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- Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached.
- Age: 20 or older
- Performance status (PS):0-1
- Case with initial therapy for postoperative primary lesion
- Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
- Reasonable organ function
- Patient must have signed informed consent.
Who cannot join
- FIGO Stages Ic(a), Ic(1) and Ic(2)
- Patients containing sarcoma elements
- Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT
- Patients with serious complications
- Patients with active infection
- Patients with intestinal paralysis or intestinal obstruction
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- Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
- Patients with previous chemotherapy or radiation therapy
- Patients with serious drug hypersensitivity
- Patients with peripheral motor/sensory neuropathy [grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0]
- Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
- 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.
- Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Trial locations and contacts
103 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
103 sites in 2 countries
Japan98 sites, 98 recruiting
- Recruiting
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558
Satoshi Yamaguchi, 81-78-929-1151, s-yama@hp.pref.hyogo.jp
- Recruiting
Kansai Rosai Hospital
Amagasaki-shi, Hyōgo, 660-8511
Kensuke Hori, 81-6-6416-1221, hori-kensuke@kansaih.johas.go.jp
- Recruiting
Tokyo Women's Medical University Medical Center East
Arakawa City, Tokyo, 116-8567
Hiroaki Nagano, 81-3-3810-1111, nagano.hiroaki@twmu.ac.jp
- Recruiting
Tokyo Medical And Dental University University Hospital of Medicine
Bunkyō-Ku, Tokyo, 113-8510
Kimio Wakana, 81-3-5803-5322, k.wakana.crm@tmd.ac.jp
- Recruiting
Nippon Medical School Hospital
Bunkyō-Ku, Tokyo, 113-8603
Keisuke Kurose, 81-3-5814-6212, kuro@nms.ac.jp
- Recruiting
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8655
Katsutoshi Oda, 81-3-3815-5411, katsutoshi-tky@umin.ac.jp
- Recruiting
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, 113-8677
Toshiharu Yasugi, 81-3-3823-2101, yasugi-tky@cick.jp
- Recruiting
Sasaki Faundation Kyoundo Hospital
Chiyoda City, Tokyo, 101-0062
Masaru Sakamoto, 81-3-3292-2051, sakamoto@po.kyoundo.jp
- Recruiting
Tokyo Metropolitan Tama Medical Center
Fuchu-shi, Tokyo, 183-8524
Akira Koyama, 81-42-323-5111, a-kohyama@live.jp
- Recruiting
Kyusyu Medical Center
Fukuoka, Fukuoka, 810-8563
Yasuyuki Hasuo, 81-92-852-0700, hasuo.yasuyuki.ab@mail.hosp.go.jp
- Recruiting
Kyusyu Cancer Center
Fukuoka, Fukuoka, 811-1395
Masao Okadome, 81-92-541-3231, okadome.m@nk-cc.go.jp
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Kiyoko Kato, 81-92-641-1151, kkato@med.kyushu-u.ac.jp
- Recruiting
Gifu University Hospital
Gifu, Gifu, 501-1194
Kenichiro Morishige, 81-58-230-6349, mken@gifu-u.ac.jp
- Recruiting
Hospital Hakodate Hokkaido
Hakodate-shi, Hokkaido, 041-8680
Tsuyoshi Yamashita, 81-138-43-2000, tyamashi@hospital.hakodate.hokkaido.jp
- Recruiting
JA Hiroshima General Hospital
Hatsukaichi-shi, Hiroshima, 738-8503
Yoshinobu Nakanishi, 81-829-36-3111, y-nakanishi@do7.enjoy.ne.jp
- Recruiting
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, 350-1241
Keiichi Fujiwara, 81-42-984-4531
fujiwara@saitama-med.ac.jp
- Recruiting
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyōgo, 670-8540
Yasushi Mizutani, 81-79-294-2251, yappy2727@yahoo.co.jp
- Recruiting
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, 036-8563
Yoshihito Yokoyama, 81-172-39-5107, yokoyama@hirosaki-u.ac.jp
- Recruiting
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, 730-8518
Junichi Kodama, 81-82-221-2291, kodama@cc.okayama-u.ac.jp
- Recruiting
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530
Yuko Shiroyama, 81-82-254-1818, y-shiroyama73182@pref.hiroshima.lg.jp
- Recruiting
Ise Red Cross Hospital
Ise-shi, Mie-ken, 516-8512
Takaharu Yamawaki, 81-596-28-2171, obgy@ise.jrc.or.jp
- Recruiting
Tokai University Hospital
Isehara-shi, Kanagawa, 259-1143
Takeshi Hirasawa, 81-463-93-1121, hira@is.icc.u-tokai.ac.jp
- Recruiting
Shimane University Hospital
Izumo, Shimane, 693-8501
Satoru Kyo, 81-853-20-2268, satoruky@med.shimane-u.ac.jp
- Recruiting
Kagoshima University Medical And Dental Hospital
Kagoshima, Kagoshima-ken, 890-8520
Hiroaki Kobayashi, 81-99-275-5111, hirokoba@m2.kufm.kagoshima-u.ac.jp
- Recruiting
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, 890-8760
Toshiaki Nakamura, 81-99-230-7000, nakamura-t53@kch.kagoshima.jp
- Recruiting
Kaizuka City Hospital
Kaizuka, Osaka, 597-0015
Takeshi Yokoi, 81-72-422-5865, t.yokoi@hosp.kaizuka.osaka.jp
- Recruiting
The Jikei University School of Medicine Kashiwa Hospital
Kashiwa-shi, Chiba, 277-8567
Hirokuni Takano, 81-4-7164-1111, hirokuni@jikei.ac.jp
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Hiroshi Tanabe, 81-4-7133-1111, htanabe@east.ncc.go.jp
- Recruiting
The Jikei University Katsushika Medical Center
Katsushika-ku, Tokyo, 125-8506
Shigeki Niimi, 81-3-3603-2111, niimi@jikei.ac.jp
- Recruiting
St.Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, 216-8511
Nao Suzuki, 81-44-977-8111, nao@marianna-u.ac.jp
- Recruiting
Kobe City Medical Center General Hospital
Kobe, Kobe, 650-0047
Shinya Yoshioka, 81-78-302-4321, s.yoshioka@kcho.jp
- Recruiting
The Jikei University Daisan Hospital
Komae-shi, Tokyo, 201-8601
Kyosuke Yamada, 81-3-3480-1151, kyosuke@jikei.ac.jp
- Recruiting
Koshigaya Municipal Hospital
Koshigaya-shi, Saitama, 343-0023
Shin Suga, 81-48-965-2221, shinsuga@juntendo.ac.jp
- Recruiting
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, 343-8555
Yoshinobu Hamada, 81-48-965-1111, hg290187-4145@tbg.t-com.ne.jp
- Recruiting
The Cancer Institute Hospital
Koto-Ku, Tokyo, 135-8550
Kazuyoshi Kato, 81-3-3520-0111, kazuyoshi.kato@jfcr.or.jp
- Recruiting
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
Hidetaka Katabuchi, 81-96-244-2111, buchi@kumamoto-u.ac.jp
- Recruiting
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Kimio Ushijima, 81-942-31-7573, kimi@med.kurume-u.ac.jp
- Recruiting
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, Kyoto, 605-0981
Tomoharu Okubo, 81-75-561-1121, tokubo@koto.kpu-m.ac.jp
- Recruiting
Gunma University Hospital
Maebashi, Gunma, 371-8511
Takashi Hirakawa, 81-27-220-7111, thira@gunma-u.ac.jp
- Recruiting
Shinshu University Hospital
Matsumoto-shi, Nagano, 390-8621
Tsutomu Miyamoto, 81-263-37-2719, tmiya@shinshu-u.ac.jp
- Recruiting
Shikoku Cancer Center
Matsuyama, Shikoku, 791-0280
Kazuhiro Takehara, 81-89-999-1111, katakehara@shikoku-cc.go.jp
- Recruiting
JA Matsuzaka Central Hospital
Matsuzaka, Mie-ken, 515-8566
Tsukio Deguchi, 81-598-21-5252, degu@mch.miekosei.or.jp
- Recruiting
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, 153-8515
Kyoko Tanaka, 81-3-3468-1251, kyoko.tanaka@med.toho-u.ac.jp
- Recruiting
Dokkyo Medical University Hospital
Mibu, Tochgi, 321-0293
Ichio Fukasawa, 81-282-86-1111, i-fuka@dokkyomed.ac.jp
- Recruiting
The Jikei University Hospital
Minato-ku, Tokyo, 105-8461
Aikou Okamoto, 81-3-3433-1111, aikou@jikei.ac.jp
- Recruiting
Miyoshi Central Hospital
Miyoshi-shi, Hiroshima, 728-8502
Takefumi Akagi, 81-824-65-0101, keioka16@gmail.com
- Recruiting
Iwate Medical University Hospital
Morioka, Iwate, 020-8505
Tsukasa Baba, 81-19-651-5111, babatsu@iwate-med.ac.jp
- Recruiting
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, 411-8777
Yasuyuki Hirashima, 81-55-989-5222, y.hirashima@scchr.jp
- Recruiting
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, 480-1195
Taiki Ueno, 81-561-62-3311, garuboxer@gmail.com
- Recruiting
Nagano Municipal Hospital
Nagano, 381-8551
Atsushi Mori, 81-26-295-1199, mori@hospital.nagano.nagano.jp
- Recruiting
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Kiyonori Miura, 81-95-819-7363, kiyonori@nagasaki-u.ac.jp
- Recruiting
Saiseikai Nagasaki Hospital
Nagasaki, 850-0003
Akira Fujishita, 81-95-826-9236, fujishita@nsaisei.or.jp
- Recruiting
Aichi Cancer Center
Nagoya, Nagoya, 464-8681
Masahiko Mori, 81-52-762-6111, mmori@aichi-cc.jp
- Recruiting
Hospital University of the Ryukyus
Nakagami-gun, Okinawa, 903-0215
Yoichi Aoki, 81-98-895-1177, yoichi@med.u-ryukyu.ac.jp
- Recruiting
Nara Prefecture General Medical Center
Nara, Nara, 630-8581
Tsunekazu Kita, 81-742-46-6001, kitatndmc@aol.com
- Recruiting
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
Takayuki Enomoto, 81-25-227-2320, enomoto@med.niigata-u.ac.jp
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Akira Kikuchi, 81-25-266-5111, akirak@niigata-cc.jp
- Recruiting
Ehime University Hospital
Onsen-gun, Ehime, 791-0295
Takashi Matsumoto, 81-89-960-5379, matsugen@m.ehime-u.ac.jp
- Recruiting
Osaka International Cancer Center
Osaka, Osaka, 537-8511
Shoji Kamiura, 81-6-6972-1181, kamiura-sh@mc.pref.osaka.jp
- Recruiting
Osaka City University Hospital
Osaka, Osaka, 545-0051
Toshiyuki Sumi, 81-6-6645-3862, sumi-toshi@med.osaka-cu.ac.jp
- Recruiting
Kindai University Hospital
Ōsaka-sayama-shi, Osaka, 589-8511
Noriomi Matsumura, 81-72-366-0221, noriomi@med.kindai.ac.jp
- Recruiting
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550
Kazuto Nakamura, 81-276-38-0771, nkazuto@gunma-cc.jp
- Recruiting
Saga University Hospital
Saga, 849-8501
Masatoshi Yokoyama, 81-952-34-2315, yokoyam1@cc.saga-u.ac.jp
- Recruiting
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0374
Takashi Onda, 81-42-778-8111, taonda@med.kitasato-u.ac.jp
- Recruiting
Jichi Medical University Saitama Medical Center
Saitama, 330-8503
Ryo Konno, 81-48-647-2111, kryo772007@yahoo.co.jp
- Recruiting
Sakai City Medical Center
Sakai, Osaka, 593-8304
Toshiya Yamamoto, 81-72-272-1199, yamamoto-to@sakai-hospital.jp
- Recruiting
JA Sapporo-Kosei general Hospital
Sapporo, Hokkaido, 060-0033
Tsunemaro Kojo, 81-11-261-5331, k.tsunemaro@ja-hokkaidoukouseiren.or.jp
- Recruiting
Hokkaido University Hospita
Sapporo, Hokkaido, 060-8648
Hidemichi Watari, 81-11-716-1161, watarih@med.hokudai.ac.jp
- Recruiting
Sapporo Medical University Hospital
Sapporo, Sapporo, 060-8543
Tsuyoshi Saito, 81-11-611-2111, tsaito@sapmed.ac.jp
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Hideki Tokunaga, 81-22-717-7000, tokunagahideki@med.tohoku.ac.jp
- Recruiting
Tosei General Hospital
Seto-shi, Aichi-ken, 489-8642
Hidekazu Asai, 81-561-82-5101, hide.asai1990@tosei.or.jp
- Recruiting
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498
Hiroyuki Fujiwara, 81-285-58-7376, fujiwara@jichi.ac.jp
- Recruiting
Saitama Cancer Center
Shinden, Saitama, 362-0806
Harushige Yokota, 81-48-722-1111, hyokota@cancer-c.pref.saitama.jp
- Recruiting
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Daisuke Aoki, 81-3-3353-1211, aoki@z7.keio.jp
- Recruiting
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666
Tsutomu Tabata, 81-3-3353-8111, tabata.tsutomu@twmu.ac.jp
- Recruiting
Japanese Red Cross Shizuoka Hospital
Shizuoka, Shizuoka, 420-0853
Yoshikazu Ichikawa, 81-54-254-4311, ichikawa-obgyn@SZRC.ORG
- Recruiting
Tokuyama Central Hospital
Shunan-shi, Yamaguchi, 745-8522
Kei Hirabayashi, 81-834-28-4411, kei0223@tokuchuhp.jp
- Recruiting
Kosei General Hospital
Suginami, Tokyo, 166-0012
Eizo Kimura, 81-3-3383-1281, eizo@cf6.so-net.ne.jp
- Recruiting
Osaka University Hospital
Suita-shi, Osaka, 565-0871
Tadashi Kimura, 81-6-6879-3351, tadashi@gyne.med.osaka-u.ac.jp
- Recruiting
Tachikawa Hospital
Tachikawa-shi, Tokyo, 190-8531
Nobumaru Hirao, 81-42-523-3131, nobumaru@1998.jukuin.keio.ac.jp
- Recruiting
Osaka Medical College Hospital
Takatsuki-shi, Osaka, 569-8686
Masahide Omichi, 81-72-683-1221, m-ohmichi@osaka-med.ac.jp
- Recruiting
National Defense Medical College Hospital
Tokorozawa-shi, Saitama, 359-8513
Masashi Takano, 81-4-2995-1151, mastkn@ndmc.ac.jp
- Recruiting
Tokushima University Hospital
Tokushima, Tokushima, 770-8503
Minoru Irahara, 81-88-633-7177, irahara@tokushima-u.ac.jp
- Recruiting
Tomishiro Central Hospital
Tomishiro-shi, Okinawa, 901-0243
Toshiyuki Maehama, 81-98-850-3811, tmaehama@yuuai.or.jp
- Recruiting
Tottori Prefectural Central Hospital
Tottori-shi, Tottori, 680-0901
Yukihisa Minagawa, 81-857-26-2271, minagawa-y@pref.tottori.jp
- Recruiting
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1193
Takuma Fujii, 81-562-93-9294, fujiit44@gmail.com
- Recruiting
Mie University Hospital
Tsu, Mie-ken, 514-8507
Eiji Kondo, 81-59-232-1111, eijikon@clin.medic.mie-u.ac.jp
- Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Toyomi Sato, 81-29-853-3049, toyomi-s@md.tsukuba.ac.jp
- Recruiting
Okinawa Prefectural Chubu Hospital
Uruma, Okinawa, 904-2293
Yoshiyuki Takahashi, 81-98-973-4111, takahashi_yoshiyuki@hosp.pref.okinawa.jp
- Recruiting
Saitama National Hospital
Wako, Saitama, 351-0102
Hiroyuki Nakagawa, 81-48-462-1101, hnakagaw@joy.ocn.ne.jp
- Recruiting
Yamagata University Hospital
Yamagata, Yamagata, 990-9585
Satoru Nagase, 81-23-628-5393, nagases@med.id.yamagata-u.ac.jp
- Recruiting
Yamaguchi Red Cross Hospital
Yamaguchi, Yamaguchi, 753-8519
Yasunobu Kanamori, 81-83-923-0111, kanamori@yamaguchi-redcross.jp
- Recruiting
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
Naho Yokota, 81-45-787-2800, nhyokota@yokohama-cu.ac.jp
- Recruiting
Yokohama Minami Kyosai Hospital
Yokohama, Kanagawa, 236-0037
Reiko Numazaki, 81-45-782-2101, r-numazaki@minamikyousai.jp
- Recruiting
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, 240-8555
Hiroyuki Shigeta, 81-45-331-1961, pgkc-0018@jcom.zaq.ne.jp
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Hisamori Kato, 81-45-520-2222, katohh@kcch.jp
- Recruiting
Tottori University Hospital
Yonago-shi, Tottori, 683-8504
Tetsuro Oishi, 81-859-38-6292, tetsuro@med.tottori-u.ac.jp
- Recruiting
Oita University Hospital
Yufu, Oita Prefecture, 879-5593
Shinpei Sato, 81-97-549-4411, m01038ss@jichi.ac.jp
South Korea5 sites, 5 recruiting
- Recruiting
National Cancer Center
Ilsandong, Goyang, 10408
Sang Yoon Park, parksang@ncc.re.kr
- Recruiting
Gachon University Gil Medical Center
Namdong, Incheon, 21565
Lee Kwang Beom, 82-32-460-2091, leekwbm@naver.com
- Recruiting
Seoul ST' Mary's Hospital
Seocho, Seoul, 137-040
KEUN HO LEE, hohoho@catholic.ac.kr
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Song Tae Jong, 82-2-2001-1943, taejong.song@gmail.com
- Recruiting
Severance Hospital
Seoul, 03722
Jung-Yun Lee, 82-1599-1004, jungyunlee@yuhs.ac
About this study
Official title: Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
Read the detailed description
Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups.
- Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types
- Facility where a subject is enrolled
- 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
- Epithelial Ovarian Cancer
- Being tested
- adjuvant chemotherapy
- Keywords
- epithelial ovarian cancer, FIGO stage I, staging surgery, adjuvant chemotherapy
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant chemotherapyDrug
Also called paclitaxel and carboplatin
combination of paclitaxel and carboplatin
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | Active comparator | combination of paclitaxel and carboplatin Receives: Drug: adjuvant chemotherapy |
| Observation | No intervention | Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
- In surviving patients, cut off will be on the last date the patient is confirmed to be alive.
- If a patient is lost to follow-up, cut off will be on the last date the patient is confirmed to be alive before being lost to follow-up.
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary outcomes (1)
Relapse-free survival
- If relapse is diagnosed through imaging, it is considered an event on the "test date" on which a "definite diagnosis" is obtained and not the test date that showed a "suspected relapse on an image." If a relapse is clinically diagnosed, not just through imaging, it is considered an event on the date on which relapse is diagnosed.
- Progression observed by CA-125 only shall not be handled as an event in this study.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start20 Jul 2012
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japanese Gynecologic Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Gynecologic Oncology Group
- Responsible party
- Sponsor
- Investigators
- Hiroshi Tanabe, M.D., Study chair, National Cancer Center Hospital East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063527
- Sponsor's protocol ID
- JGOG3020
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No