Phase III Trial of Stage I Ovarian Cancer After Surgery

Last updated: August 28, 2019
Sponsor: Japanese Gynecologic Oncology Group
Overall Status: Active - Recruiting

Phase

3

Condition

Ovarian Cysts

Treatment

N/A

Clinical Study ID

NCT04063527
JGOG3020
  • Ages > 20
  • Female

Study Summary

To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with a diagnosis of histopathologically epithelial ovarian cancer

  2. FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) andIc(b)(all degree of differentiation and all histologic type)

  3. Patients with a diagnosis of advanced stage by comprehensive staging or restaginglaparotomy.

  4. Patients who received comprehensive staging surgery (basic surgical techniques (totalhysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritonealcytology, multiple biopsies of the peritoneum ([Peritoneal biopsy] see details below),retroperitoneal lymph node dissection (see details below [Retroperitoneal lymph nodedissection]). However, for the following cases, it is eligible as a condition to record on theofficial document.

  • Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic andpalpation in the stipulated site, and the case that biopsy has not beenperformed.

  • Retroperitoneal lymph node dissection: the case that lymph nodes of thestipulated range has been dissected however the prescribed number has not beenreached.

  1. Age: 20 or older

  2. Performance status (PS):0-1

  3. Case with initial therapy for postoperative primary lesion

  4. Patient possible to receive the first study treatment within 8 weeks after thecomprehensive staging surgery

  5. Reasonable organ function

  6. Patient must have signed informed consent.

Exclusion

Exclusion Criteria:

  1. FIGO Stages Ic(a), Ic(1) and Ic(2)

  2. Patients containing sarcoma elements

  3. Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chestradiography 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 TerminologyCriteria for Adverse Events (CTCAE) 4.0]

  11. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenatedcastor oil

  12. Patients with positive HBsAg. Patients with more than 2.1 log/copies ml based on fixedHepatitis 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 bythe treating physician

Study Design

Total Participants: 360
Study Start date:
July 20, 2012
Estimated Completion Date:
February 01, 2030

Study Description

Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups.

  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.

Connect with a study center

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi 480-1195
    Japan

    Active - Recruiting

  • Tosei General Hospital

    Seto-shi, Aichi 489-8642
    Japan

    Active - Recruiting

  • Fujita Health University Hospital

    Toyoake-shi, Aichi 470-1193
    Japan

    Active - Recruiting

  • Hirosaki University School of Medicine & Hospital

    Hirosaki-shi, Aomori 036-8563
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba 277-8577
    Japan

    Active - Recruiting

  • The Jikei University School of Medicine Kashiwa Hospital

    Kashiwa-shi, Chiba 277-8567
    Japan

    Active - Recruiting

  • Ehime University Hospital

    Onsen-gun, Ehime 791-0295
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Kyusyu Cancer Center

    Fukuoka-shi, Fukuoka 811-1395
    Japan

    Active - Recruiting

  • Kyusyu Medical Center

    Fukuoka-shi, Fukuoka 810-8563
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume-shi, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Gifu University Hospital

    Gifu-shi, Gifu 501-1194
    Japan

    Active - Recruiting

  • Gunma University Hospital

    Maebashi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Gunma Prefectural Cancer Center

    Ōta, Gunma 373-8550
    Japan

    Active - Recruiting

  • JA Hiroshima General Hospital

    Hatsukaichi-shi, Hiroshima 738-8503
    Japan

    Active - Recruiting

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima-shi, Hiroshima 730-8518
    Japan

    Active - Recruiting

  • Hiroshima Prefectural Hospital

    Hiroshima-shi, Hiroshima 734-8530
    Japan

    Active - Recruiting

  • Miyoshi Central Hospital

    Miyoshi-shi, Hiroshima 728-8502
    Japan

    Active - Recruiting

  • Hospital Hakodate Hokkaido

    Hakodate-shi, Hokkaido 041-8680
    Japan

    Active - Recruiting

  • Hokkaido University Hospita

    Sapporo-shi, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • JA Sapporo-Kosei general Hospital

    Sapporo-shi, Hokkaido 060-0033
    Japan

    Active - Recruiting

  • Hyogo Cancer Center

    Akashi-shi, Hyogo 673-8558
    Japan

    Active - Recruiting

  • Kansai Rosai Hospital

    Amagasaki-shi, Hyogo 660-8511
    Japan

    Active - Recruiting

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyogo 670-8540
    Japan

    Active - Recruiting

  • University of Tsukuba Hospital

    Tsukuba-shi, Ibaraki 305-8576
    Japan

    Active - Recruiting

  • Iwate Medical University Hospital

    Morioka-shi, Iwate 020-8505
    Japan

    Active - Recruiting

  • Kagoshima City Hospital

    Kagoshima-shi, Kagoshima 890-8760
    Japan

    Active - Recruiting

  • Kagoshima University Medical And Dental Hospital

    Kagoshima-shi, Kagoshima 890-8520
    Japan

    Active - Recruiting

  • Tokai University Hospital

    Isehara-shi, Kanagawa 259-1143
    Japan

    Active - Recruiting

  • St.Marianna University School of Medicine Hospital

    Kawasaki-shi, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • Kitasato University Hospital

    Sagamihara, Kanagawa 252-0374
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa 241-8515
    Japan

    Active - Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa 236-0004
    Japan

    Active - Recruiting

  • Yokohama Minami Kyosai Hospital

    Yokohama, Kanagawa 236-0037
    Japan

    Active - Recruiting

  • Yokohama Municipal Citizen's Hospital

    Yokohama-shi, Kanagawa 240-8555
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Kobe-shi, Kobe 650-0047
    Japan

    Active - Recruiting

  • Kumamoto University Hospital

    Kumamoto-shi, Kumamoto 860-8556
    Japan

    Active - Recruiting

  • Japanese Red Cross Kyoto Daiichi Hospital

    KYoto-shi, Kyoto 605-0981
    Japan

    Active - Recruiting

  • Ise Red Cross Hospital

    Ise-shi, Mie 516-8512
    Japan

    Active - Recruiting

  • JA Matsuzaka Central Hospital

    Matsuzaka, Mie 515-8566
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu, Mie 514-8507
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Shinshu University Hospital

    Matsumoto-shi, Nagano 390-8621
    Japan

    Active - Recruiting

  • Nagasaki University Hospital

    Nagasaki-shi, Nagasaki 852-8501
    Japan

    Active - Recruiting

  • Aichi Cancer Center

    Nagoya-shi, Nagoya 464-8681
    Japan

    Active - Recruiting

  • Nara Prefecture General Medical Center

    Nara-shi, Nara 630-8581
    Japan

    Active - Recruiting

  • Niigata Cancer Center Hospital

    Niigata-shi, Niigata 951-8566
    Japan

    Active - Recruiting

  • Niigata University Medical and Dental Hospital

    Niigata-shi, Niigata 951-8520
    Japan

    Active - Recruiting

  • Oita University Hospital

    Yufu, Oita 879-5593
    Japan

    Active - Recruiting

  • Hospital University of the Ryukyus

    Nakagami-gun, Okinawa 903-0215
    Japan

    Active - Recruiting

  • Tomishiro Central Hospital

    Tomishiro-shi, Okinawa 901-0243
    Japan

    Active - Recruiting

  • Okinawa Prefectural Chubu Hospital

    Uruma-shi, Okinawa 904-2293
    Japan

    Active - Recruiting

  • Kaizuka City Hospital

    Kaizuka, Osaka 597-0015
    Japan

    Active - Recruiting

  • Osaka City University Hospital

    Osaka-shi, Osaka 545-0051
    Japan

    Active - Recruiting

  • Osaka International Cancer Center

    Osaka-shi, Osaka 537-8511
    Japan

    Active - Recruiting

  • Sakai City Medical Center

    Sakai, Osaka 593-8304
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita-shi, Osaka 565-0871
    Japan

    Active - Recruiting

  • Osaka Medical College Hospital

    Takatsuki-shi, Osaka 569-8686
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Ōsaka-sayama-shi, Osaka 589-8511
    Japan

    Active - Recruiting

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama 350-1241
    Japan

    Active - Recruiting

  • Saitama Cancer Center

    Ina, Saitama 362-0806
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya-shi, Saitama 343-8555
    Japan

    Active - Recruiting

  • Koshigaya Municipal Hospital

    Koshigaya-shi, Saitama 343-0023
    Japan

    Active - Recruiting

  • National Defense Medical College Hospital

    Tokorozawa-shi, Saitama 359-8513
    Japan

    Active - Recruiting

  • Saitama National Hospital

    Wako, Saitama 351-0102
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital

    Sapporo-shi, Sapporo 060-8543
    Japan

    Active - Recruiting

  • Shikoku Cancer Center

    Matsuyama-shi, Shikoku 791-0280
    Japan

    Active - Recruiting

  • Shimane University Hospital

    Izumo, Shimane 693-8501
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-chō, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka-shi, Shizuoka 420-0853
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital

    Mibu, Tochgi 321-0293
    Japan

    Active - Recruiting

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi 329-0498
    Japan

    Active - Recruiting

  • Tokushima University Hospital

    Tokushima-shi, Tokushima 770-8503
    Japan

    Active - Recruiting

  • Tokyo Women's Medical University Medical Center East

    Arakawa, Tokyo 116-8567
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Bunkyō-Ku, Tokyo 113-8603
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital

    Bunkyō-Ku, Tokyo 113-8655
    Japan

    Active - Recruiting

  • Tokyo Medical And Dental University University Hospital of Medicine

    Bunkyō-Ku, Tokyo 113-8510
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyō-Ku, Tokyo 113-8677
    Japan

    Active - Recruiting

  • Sasaki Faundation Kyoundo Hospital

    Chiyoda, Tokyo 101-0062
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Tama Medical Center

    Fuchu-shi, Tokyo 183-8524
    Japan

    Active - Recruiting

  • The Jikei University Katsushika Medical Center

    Katsushika-ku, Tokyo 125-8506
    Japan

    Active - Recruiting

  • The Jikei University Daisan Hospital

    Komae-shi, Tokyo 201-8601
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital

    Koto-Ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo 153-8515
    Japan

    Active - Recruiting

  • The Jikei University Hospital

    Minato-ku, Tokyo 105-8461
    Japan

    Active - Recruiting

  • Tokyo Women's Medical University Hospital

    Shinjuku-Ku, Tokyo 162-8666
    Japan

    Active - Recruiting

  • Keio University Hospital

    Shinjuku-ku, Tokyo 160-8582
    Japan

    Active - Recruiting

  • Kosei General Hospital

    Suginami, Tokyo 166-0012
    Japan

    Active - Recruiting

  • Tachikawa Hospital

    Tachikawa-shi, Tokyo 190-8531
    Japan

    Active - Recruiting

  • Tottori Prefectural Central Hospital

    Tottori-shi, Tottori 680-0901
    Japan

    Active - Recruiting

  • Tottori University Hospital

    Yonago-shi, Tottori 683-8504
    Japan

    Active - Recruiting

  • Yamagata University Hospital

    Yamagata-shi, Yamagata 990-9585
    Japan

    Active - Recruiting

  • Tokuyama Central Hospital

    Shunan-shi, Yamaguchi 745-8522
    Japan

    Active - Recruiting

  • Yamaguchi Red Cross Hospital

    Yamaguchi-shi, Yamaguchi 753-8519
    Japan

    Active - Recruiting

  • Nagano Municipal Hospital

    Nagano, 381-8551
    Japan

    Active - Recruiting

  • Saiseikai Nagasaki Hospital

    Nagasaki, 850-0003
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Active - Recruiting

  • Jichi Medical University Saitama Medical Center

    Saitama, 330-8503
    Japan

    Active - Recruiting

  • National Cancer Center

    Ilsandong, Goyang 10408
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Namdong, Incheon 21565
    Korea, Republic of

    Active - Recruiting

  • Seoul ST' Mary's Hospital

    Seocho, Seoul 137-040
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.