Actively Recruiting

Phase 3
Age: 20Years +
FEMALE
NCT04063527

Phase III Trial of Stage I Ovarian Cancer After Surgery

Led by Japanese Gynecologic Oncology Group · Updated on 2019-08-30

360

Participants Needed

103

Research Sites

915 weeks

Total Duration

On this page

Sponsors

J

Japanese Gynecologic Oncology Group

Lead Sponsor

K

Korean Gynecologic Oncology Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Phase III Trial of Stage I Ovarian Cancer After Surgery

Who Can Participate

Age: 20Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with histopathologically confirmed epithelial ovarian cancer
  • FIGO stages Ia (Grade 2/3, clear cell carcinoma), Ib (Grade 2/3, clear cell carcinoma), or Ic(b) of any differentiation or histologic type
  • Diagnosis of advanced stage confirmed by comprehensive staging or restaging laparotomy
  • Completion of comprehensive staging surgery including total hysterectomy, bilateral salpingo-oophorectomy, omentectomy, peritoneal cytology, multiple peritoneal biopsies, and retroperitoneal lymph node dissection, with some exceptions documented
  • Age 20 years or older
  • Performance status of 0 or 1
  • Initial therapy for postoperative primary lesion
  • Ability to receive first study treatment within 8 weeks after surgery
  • Reasonable organ function
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • FIGO stages Ic(a), Ic(1), and Ic(2)
  • Presence of sarcoma elements
  • Signs of interstitial pneumonia or pulmonary fibrosis on chest X-ray or CT
  • Serious complications or active infections
  • Intestinal paralysis or obstruction
  • Synchronous malignancy or metachronous malignancy with less than 5 years progression-free
  • Previous chemotherapy or radiation therapy
  • Serious drug hypersensitivity
  • Peripheral motor or sensory neuropathy grade 2 or higher
  • Hypersensitivity to polyoxyethylated or hydrogenated castor oil
  • Positive hepatitis B surface antigen or high HBV-DNA levels
  • Any safety concerns as judged by the treating physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 103 locations

1

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, Japan, 480-1195

Actively Recruiting

2

Tosei General Hospital

Seto-shi, Aichi-ken, Japan, 489-8642

Actively Recruiting

3

Fujita Health University Hospital

Toyoake-shi, Aichi-ken, Japan, 470-1193

Actively Recruiting

4

Hirosaki University School of Medicine & Hospital

Hirosaki-shi, Aomori, Japan, 036-8563

Actively Recruiting

5

The Jikei University School of Medicine Kashiwa Hospital

Kashiwa-shi, Chiba, Japan, 277-8567

Actively Recruiting

6

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan, 277-8577

Actively Recruiting

7

Ehime University Hospital

Onsen-gun, Ehime, Japan, 791-0295

Actively Recruiting

8

Kyusyu Medical Center

Fukuoka, Fukuoka, Japan, 810-8563

Actively Recruiting

9

Kyusyu Cancer Center

Fukuoka, Fukuoka, Japan, 811-1395

Actively Recruiting

10

Kyushu University Hospital

Fukuoka, Fukuoka, Japan, 812-8582

Actively Recruiting

11

Kurume University Hospital

Kurume-shi, Fukuoka, Japan, 830-0011

Actively Recruiting

12

Gifu University Hospital

Gifu, Gifu, Japan, 501-1194

Actively Recruiting

13

Gunma University Hospital

Maebashi, Gunma, Japan, 371-8511

Actively Recruiting

14

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan, 373-8550

Actively Recruiting

15

JA Hiroshima General Hospital

Hatsukaichi-shi, Hiroshima, Japan, 738-8503

Actively Recruiting

16

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Hiroshima, Japan, 730-8518

Actively Recruiting

17

Hiroshima Prefectural Hospital

Hiroshima, Hiroshima, Japan, 734-8530

Actively Recruiting

18

Miyoshi Central Hospital

Miyoshi-shi, Hiroshima, Japan, 728-8502

Actively Recruiting

19

Hospital Hakodate Hokkaido

Hakodate-shi, Hokkaido, Japan, 041-8680

Actively Recruiting

20

JA Sapporo-Kosei general Hospital

Sapporo, Hokkaido, Japan, 060-0033

Actively Recruiting

21

Hokkaido University Hospita

Sapporo, Hokkaido, Japan, 060-8648

Actively Recruiting

22

Hyogo Cancer Center

Akashi-shi, Hyōgo, Japan, 673-8558

Actively Recruiting

23

Kansai Rosai Hospital

Amagasaki-shi, Hyōgo, Japan, 660-8511

Actively Recruiting

24

Japanese Red Cross Society Himeji Hospital

Himeji-shi, Hyōgo, Japan, 670-8540

Actively Recruiting

25

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan, 305-8576

Actively Recruiting

26

Iwate Medical University Hospital

Morioka, Iwate, Japan, 020-8505

Actively Recruiting

27

Kagoshima University Medical And Dental Hospital

Kagoshima, Kagoshima-ken, Japan, 890-8520

Actively Recruiting

28

Kagoshima City Hospital

Kagoshima, Kagoshima-ken, Japan, 890-8760

Actively Recruiting

29

Tokai University Hospital

Isehara-shi, Kanagawa, Japan, 259-1143

Actively Recruiting

30

St.Marianna University School of Medicine Hospital

Kawasaki-shi, Kanagawa, Japan, 216-8511

Actively Recruiting

31

Kitasato University Hospital

Sagamihara, Kanagawa, Japan, 252-0374

Actively Recruiting

32

Yokohama City University Hospital

Yokohama, Kanagawa, Japan, 236-0004

Actively Recruiting

33

Yokohama Minami Kyosai Hospital

Yokohama, Kanagawa, Japan, 236-0037

Actively Recruiting

34

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, Japan, 240-8555

Actively Recruiting

35

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan, 241-8515

Actively Recruiting

36

Kobe City Medical Center General Hospital

Kobe, Kobe, Japan, 650-0047

Actively Recruiting

37

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan, 860-8556

Actively Recruiting

38

Japanese Red Cross Kyoto Daiichi Hospital

Kyoto, Kyoto, Japan, 605-0981

Actively Recruiting

39

Ise Red Cross Hospital

Ise-shi, Mie-ken, Japan, 516-8512

Actively Recruiting

40

JA Matsuzaka Central Hospital

Matsuzaka, Mie-ken, Japan, 515-8566

Actively Recruiting

41

Mie University Hospital

Tsu, Mie-ken, Japan, 514-8507

Actively Recruiting

42

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

Actively Recruiting

43

Shinshu University Hospital

Matsumoto-shi, Nagano, Japan, 390-8621

Actively Recruiting

44

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan, 852-8501

Actively Recruiting

45

Aichi Cancer Center

Nagoya, Nagoya, Japan, 464-8681

Actively Recruiting

46

Nara Prefecture General Medical Center

Nara, Nara, Japan, 630-8581

Actively Recruiting

47

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan, 951-8520

Actively Recruiting

48

Niigata Cancer Center Hospital

Niigata, Niigata, Japan, 951-8566

Actively Recruiting

49

Oita University Hospital

Yufu, Oita Prefecture, Japan, 879-5593

Actively Recruiting

50

Hospital University of the Ryukyus

Nakagami-gun, Okinawa, Japan, 903-0215

Actively Recruiting

51

Tomishiro Central Hospital

Tomishiro-shi, Okinawa, Japan, 901-0243

Actively Recruiting

52

Okinawa Prefectural Chubu Hospital

Uruma, Okinawa, Japan, 904-2293

Actively Recruiting

53

Kaizuka City Hospital

Kaizuka, Osaka, Japan, 597-0015

Actively Recruiting

54

Osaka International Cancer Center

Osaka, Osaka, Japan, 537-8511

Actively Recruiting

55

Osaka City University Hospital

Osaka, Osaka, Japan, 545-0051

Actively Recruiting

56

Kindai University Hospital

Ōsaka-sayama-shi, Osaka, Japan, 589-8511

Actively Recruiting

57

Sakai City Medical Center

Sakai, Osaka, Japan, 593-8304

Actively Recruiting

58

Osaka University Hospital

Suita-shi, Osaka, Japan, 565-0871

Actively Recruiting

59

Osaka Medical College Hospital

Takatsuki-shi, Osaka, Japan, 569-8686

Actively Recruiting

60

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan, 350-1241

Actively Recruiting

61

Koshigaya Municipal Hospital

Koshigaya-shi, Saitama, Japan, 343-0023

Actively Recruiting

62

Dokkyo Medical University Saitama Medical Center

Koshigaya-shi, Saitama, Japan, 343-8555

Actively Recruiting

63

Saitama Cancer Center

Shinden, Saitama, Japan, 362-0806

Actively Recruiting

64

National Defense Medical College Hospital

Tokorozawa-shi, Saitama, Japan, 359-8513

Actively Recruiting

65

Saitama National Hospital

Wako, Saitama, Japan, 351-0102

Actively Recruiting

66

Sapporo Medical University Hospital

Sapporo, Sapporo, Japan, 060-8543

Actively Recruiting

67

Shikoku Cancer Center

Matsuyama, Shikoku, Japan, 791-0280

Actively Recruiting

68

Shimane University Hospital

Izumo, Shimane, Japan, 693-8501

Actively Recruiting

69

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, Japan, 411-8777

Actively Recruiting

70

Japanese Red Cross Shizuoka Hospital

Shizuoka, Shizuoka, Japan, 420-0853

Actively Recruiting

71

Dokkyo Medical University Hospital

Mibu, Tochgi, Japan, 321-0293

Actively Recruiting

72

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan, 329-0498

Actively Recruiting

73

Tokushima University Hospital

Tokushima, Tokushima, Japan, 770-8503

Actively Recruiting

74

Tokyo Women's Medical University Medical Center East

Arakawa City, Tokyo, Japan, 116-8567

Actively Recruiting

75

Tokyo Medical And Dental University University Hospital of Medicine

Bunkyō-Ku, Tokyo, Japan, 113-8510

Actively Recruiting

76

Nippon Medical School Hospital

Bunkyō-Ku, Tokyo, Japan, 113-8603

Actively Recruiting

77

The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan, 113-8655

Actively Recruiting

78

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyō-Ku, Tokyo, Japan, 113-8677

Actively Recruiting

79

Sasaki Faundation Kyoundo Hospital

Chiyoda City, Tokyo, Japan, 101-0062

Actively Recruiting

80

Tokyo Metropolitan Tama Medical Center

Fuchu-shi, Tokyo, Japan, 183-8524

Actively Recruiting

81

The Jikei University Katsushika Medical Center

Katsushika-ku, Tokyo, Japan, 125-8506

Actively Recruiting

82

The Jikei University Daisan Hospital

Komae-shi, Tokyo, Japan, 201-8601

Actively Recruiting

83

The Cancer Institute Hospital

Koto-Ku, Tokyo, Japan, 135-8550

Actively Recruiting

84

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, Japan, 153-8515

Actively Recruiting

85

The Jikei University Hospital

Minato-ku, Tokyo, Japan, 105-8461

Actively Recruiting

86

Keio University Hospital

Shinjuku-ku, Tokyo, Japan, 160-8582

Actively Recruiting

87

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, Japan, 162-8666

Actively Recruiting

88

Kosei General Hospital

Suginami, Tokyo, Japan, 166-0012

Actively Recruiting

89

Tachikawa Hospital

Tachikawa-shi, Tokyo, Japan, 190-8531

Actively Recruiting

90

Tottori Prefectural Central Hospital

Tottori-shi, Tottori, Japan, 680-0901

Actively Recruiting

91

Tottori University Hospital

Yonago-shi, Tottori, Japan, 683-8504

Actively Recruiting

92

Yamagata University Hospital

Yamagata, Yamagata, Japan, 990-9585

Actively Recruiting

93

Tokuyama Central Hospital

Shunan-shi, Yamaguchi, Japan, 745-8522

Actively Recruiting

94

Yamaguchi Red Cross Hospital

Yamaguchi, Yamaguchi, Japan, 753-8519

Actively Recruiting

95

Nagano Municipal Hospital

Nagano, Japan, 381-8551

Actively Recruiting

96

Saiseikai Nagasaki Hospital

Nagasaki, Japan, 850-0003

Actively Recruiting

97

Saga University Hospital

Saga, Japan, 849-8501

Actively Recruiting

98

Jichi Medical University Saitama Medical Center

Saitama, Japan, 330-8503

Actively Recruiting

99

National Cancer Center

Ilsandong, Goyang, South Korea, 10408

Actively Recruiting

100

Gachon University Gil Medical Center

Namdong, Incheon, South Korea, 21565

Actively Recruiting

101

Seoul ST' Mary's Hospital

Seocho, Seoul, South Korea, 137-040

Actively Recruiting

102

Kangbuk Samsung Hospital

Seoul, South Korea, 03181

Actively Recruiting

103

Severance Hospital

Seoul, South Korea, 03722

Actively Recruiting

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Research Team

H

Hiroshi Tanabe, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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