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| Name | Class |
|---|---|
| Korean Gynecologic Oncology Group | OTHER |
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To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy | Active Comparator | combination of paclitaxel and carboplatin |
|
| Observation | No Intervention | Observation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant chemotherapy | Drug | combination of paclitaxel and carboplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival |
| From date of randomization until the date of death from any cause, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival |
|
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiroshi Tanabe, M.D. | Contact | 81-4-7133-1111 | htanabe@east.ncc.go.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hiroshi Tanabe, M.D. | National Cancer Center Hospital East | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Recruiting | Nagakute-shi | Aichi-ken | 480-1195 | Japan |
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| 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 |
| Tosei General Hospital | Recruiting | Seto-shi | Aichi-ken | 489-8642 | Japan |
|
| Fujita Health University Hospital | Recruiting | Toyoake-shi | Aichi-ken | 470-1193 | Japan |
|
| Hirosaki University School of Medicine & Hospital | Recruiting | Hirosaki-shi | Aomori | 036-8563 | Japan |
|
| The Jikei University School of Medicine Kashiwa Hospital | Recruiting | Kashiwa-shi | Chiba | 277-8567 | Japan |
|
| National Cancer Center Hospital East | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
|
| Ehime University Hospital | Recruiting | Onsen-gun | Ehime | 791-0295 | Japan |
|
| Kyusyu Medical Center | Recruiting | Fukuoka | Fukuoka | 810-8563 | Japan |
|
| Kyusyu Cancer Center | Recruiting | Fukuoka | Fukuoka | 811-1395 | Japan |
|
| Kyushu University Hospital | Recruiting | Fukuoka | Fukuoka | 812-8582 | Japan |
|
| Kurume University Hospital | Recruiting | Kurume-shi | Fukuoka | 830-0011 | Japan |
|
| Gifu University Hospital | Recruiting | Gifu | Gifu | 501-1194 | Japan |
|
| Gunma University Hospital | Recruiting | Maebashi | Gunma | 371-8511 | Japan |
|
| Gunma Prefectural Cancer Center | Recruiting | Ōta | Gunma | 373-8550 | Japan |
|
| JA Hiroshima General Hospital | Recruiting | Hatsukaichi-shi | Hiroshima | 738-8503 | Japan |
|
| Hiroshima City Hiroshima Citizens Hospital | Recruiting | Hiroshima | Hiroshima | 730-8518 | Japan |
|
| Hiroshima Prefectural Hospital | Recruiting | Hiroshima | Hiroshima | 734-8530 | Japan |
|
| Miyoshi Central Hospital | Recruiting | Miyoshi-shi | Hiroshima | 728-8502 | Japan |
|
| Hospital Hakodate Hokkaido | Recruiting | Hakodate-shi | Hokkaido | 041-8680 | Japan |
|
| JA Sapporo-Kosei general Hospital | Recruiting | Sapporo | Hokkaido | 060-0033 | Japan |
|
| Hokkaido University Hospita | Recruiting | Sapporo | Hokkaido | 060-8648 | Japan |
|
| Hyogo Cancer Center | Recruiting | Akashi-shi | Hyōgo | 673-8558 | Japan |
|
| Kansai Rosai Hospital | Recruiting | Amagasaki-shi | Hyōgo | 660-8511 | Japan |
|
| Japanese Red Cross Society Himeji Hospital | Recruiting | Himeji-shi | Hyōgo | 670-8540 | Japan |
|
| University of Tsukuba Hospital | Recruiting | Tsukuba | Ibaraki | 305-8576 | Japan |
|
| Iwate Medical University Hospital | Recruiting | Morioka | Iwate | 020-8505 | Japan |
|
| Kagoshima University Medical And Dental Hospital | Recruiting | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
|
| Kagoshima City Hospital | Recruiting | Kagoshima | Kagoshima-ken | 890-8760 | Japan |
|
| Tokai University Hospital | Recruiting | Isehara-shi | Kanagawa | 259-1143 | Japan |
|
| St.Marianna University School of Medicine Hospital | Recruiting | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
|
| Kitasato University Hospital | Recruiting | Sagamihara | Kanagawa | 252-0374 | Japan |
|
| Yokohama City University Hospital | Recruiting | Yokohama | Kanagawa | 236-0004 | Japan |
|
| Yokohama Minami Kyosai Hospital | Recruiting | Yokohama | Kanagawa | 236-0037 | Japan |
|
| Yokohama Municipal Citizen's Hospital | Recruiting | Yokohama | Kanagawa | 240-8555 | Japan |
|
| Kanagawa Cancer Center | Recruiting | Yokohama | Kanagawa | 241-8515 | Japan |
|
| Kobe City Medical Center General Hospital | Recruiting | Kobe | Kobe | 650-0047 | Japan |
|
| Kumamoto University Hospital | Recruiting | Kumamoto | Kumamoto | 860-8556 | Japan |
|
| Japanese Red Cross Kyoto Daiichi Hospital | Recruiting | Kyoto | Kyoto | 605-0981 | Japan |
|
| Ise Red Cross Hospital | Recruiting | Ise-shi | Mie-ken | 516-8512 | Japan |
|
| JA Matsuzaka Central Hospital | Recruiting | Matsuzaka | Mie-ken | 515-8566 | Japan |
|
| Mie University Hospital | Recruiting | Tsu | Mie-ken | 514-8507 | Japan |
|
| Tohoku University Hospital | Recruiting | Sendai | Miyagi | 980-8574 | Japan |
|
| Shinshu University Hospital | Recruiting | Matsumoto-shi | Nagano | 390-8621 | Japan |
|
| Nagasaki University Hospital | Recruiting | Nagasaki | Nagasaki | 852-8501 | Japan |
|
| Aichi Cancer Center | Recruiting | Nagoya | Nagoya | 464-8681 | Japan |
|
| Nara Prefecture General Medical Center | Recruiting | Nara | Nara | 630-8581 | Japan |
|
| Niigata University Medical and Dental Hospital | Recruiting | Niigata | Niigata | 951-8520 | Japan |
|
| Niigata Cancer Center Hospital | Recruiting | Niigata | Niigata | 951-8566 | Japan |
|
| Oita University Hospital | Recruiting | Yufu | Oita Prefecture | 879-5593 | Japan |
|
| Hospital University of the Ryukyus | Recruiting | Nakagami-gun | Okinawa | 903-0215 | Japan |
|
| Tomishiro Central Hospital | Recruiting | Tomishiro-shi | Okinawa | 901-0243 | Japan |
|
| Okinawa Prefectural Chubu Hospital | Recruiting | Uruma | Okinawa | 904-2293 | Japan |
|
| Kaizuka City Hospital | Recruiting | Kaizuka | Osaka | 597-0015 | Japan |
|
| Osaka International Cancer Center | Recruiting | Osaka | Osaka | 537-8511 | Japan |
|
| Osaka City University Hospital | Recruiting | Osaka | Osaka | 545-0051 | Japan |
|
| Kindai University Hospital | Recruiting | Ōsaka-sayama-shi | Osaka | 589-8511 | Japan |
|
| Sakai City Medical Center | Recruiting | Sakai | Osaka | 593-8304 | Japan |
|
| Osaka University Hospital | Recruiting | Suita-shi | Osaka | 565-0871 | Japan |
|
| Osaka Medical College Hospital | Recruiting | Takatsuki-shi | Osaka | 569-8686 | Japan |
|
| Saitama Medical University International Medical Center | Recruiting | Hidaka-shi | Saitama | 350-1241 | Japan |
|
| Koshigaya Municipal Hospital | Recruiting | Koshigaya-shi | Saitama | 343-0023 | Japan |
|
| Dokkyo Medical University Saitama Medical Center | Recruiting | Koshigaya-shi | Saitama | 343-8555 | Japan |
|
| Saitama Cancer Center | Recruiting | Shinden | Saitama | 362-0806 | Japan |
|
| National Defense Medical College Hospital | Recruiting | Tokorozawa-shi | Saitama | 359-8513 | Japan |
|
| Saitama National Hospital | Recruiting | Wako | Saitama | 351-0102 | Japan |
|
| Sapporo Medical University Hospital | Recruiting | Sapporo | Sapporo | 060-8543 | Japan |
|
| Shikoku Cancer Center | Recruiting | Matsuyama | Shikoku | 791-0280 | Japan |
|
| Shimane University Hospital | Recruiting | Izumo | Shimane | 693-8501 | Japan |
|
| Shizuoka Cancer Center | Recruiting | Nagaizumi-chō | Shizuoka | 411-8777 | Japan |
|
| Japanese Red Cross Shizuoka Hospital | Recruiting | Shizuoka | Shizuoka | 420-0853 | Japan |
|
| Dokkyo Medical University Hospital | Recruiting | Mibu | Tochgi | 321-0293 | Japan |
|
| Jichi Medical University Hospital | Recruiting | Shimotsuke-shi | Tochigi | 329-0498 | Japan |
|
| Tokushima University Hospital | Recruiting | Tokushima | Tokushima | 770-8503 | Japan |
|
| Tokyo Women's Medical University Medical Center East | Recruiting | Arakawa City | Tokyo | 116-8567 | Japan |
|
| Tokyo Medical And Dental University University Hospital of Medicine | Recruiting | Bunkyō-Ku | Tokyo | 113-8510 | Japan |
|
| Nippon Medical School Hospital | Recruiting | Bunkyō-Ku | Tokyo | 113-8603 | Japan |
|
| The University of Tokyo Hospital | Recruiting | Bunkyō-Ku | Tokyo | 113-8655 | Japan |
|
| Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital | Recruiting | Bunkyō-Ku | Tokyo | 113-8677 | Japan |
|
| Sasaki Faundation Kyoundo Hospital | Recruiting | Chiyoda City | Tokyo | 101-0062 | Japan |
|
| Tokyo Metropolitan Tama Medical Center | Recruiting | Fuchu-shi | Tokyo | 183-8524 | Japan |
|
| The Jikei University Katsushika Medical Center | Recruiting | Katsushika-ku | Tokyo | 125-8506 | Japan |
|
| The Jikei University Daisan Hospital | Recruiting | Komae-shi | Tokyo | 201-8601 | Japan |
|
| The Cancer Institute Hospital | Recruiting | Koto-Ku | Tokyo | 135-8550 | Japan |
|
| Toho University Ohashi Medical Center | Recruiting | Meguro-ku | Tokyo | 153-8515 | Japan |
|
| The Jikei University Hospital | Recruiting | Minato-ku | Tokyo | 105-8461 | Japan |
|
| Keio University Hospital | Recruiting | Shinjuku-ku | Tokyo | 160-8582 | Japan |
|
| Tokyo Women's Medical University Hospital | Recruiting | Shinjuku-Ku | Tokyo | 162-8666 | Japan |
|
| Kosei General Hospital | Recruiting | Suginami | Tokyo | 166-0012 | Japan |
|
| Tachikawa Hospital | Recruiting | Tachikawa-shi | Tokyo | 190-8531 | Japan |
|
| Tottori Prefectural Central Hospital | Recruiting | Tottori-shi | Tottori | 680-0901 | Japan |
|
| Tottori University Hospital | Recruiting | Yonago-shi | Tottori | 683-8504 | Japan |
|
| Yamagata University Hospital | Recruiting | Yamagata | Yamagata | 990-9585 | Japan |
|
| Tokuyama Central Hospital | Recruiting | Shunan-shi | Yamaguchi | 745-8522 | Japan |
|
| Yamaguchi Red Cross Hospital | Recruiting | Yamaguchi | Yamaguchi | 753-8519 | Japan |
|
| Nagano Municipal Hospital | Recruiting | Nagano | 381-8551 | Japan |
|
| Saiseikai Nagasaki Hospital | Recruiting | Nagasaki | 850-0003 | Japan |
|
| Saga University Hospital | Recruiting | Saga | 849-8501 | Japan |
|
| Jichi Medical University Saitama Medical Center | Recruiting | Saitama | 330-8503 | Japan |
|
| National Cancer Center | Recruiting | Ilsandong | Goyang | 10408 | South Korea |
|
| Gachon University Gil Medical Center | Recruiting | Namdong | Incheon | 21565 | South Korea |
|
| Seoul ST' Mary's Hospital | Recruiting | Seocho | Seoul | 137-040 | South Korea |
|
| Kangbuk Samsung Hospital | Recruiting | Seoul | 03181 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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