Phase III Trial of Stage I Ovarian Cancer After Surgery

August 28, 2019 updated by: Japanese Gynecologic Oncology Group

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Nagano, Japan, 381-8551
      • Nagasaki, Japan, 850-0003
        • Recruiting
        • Saiseikai Nagasaki Hospital
        • Contact:
      • Saga, Japan, 849-8501
        • Recruiting
        • Saga University Hospital
        • Contact:
      • Saitama, Japan, 330-8503
        • Recruiting
        • Jichi Medical University Saitama Medical Center
        • Contact:
    • Aichi
      • Nagakute-shi, Aichi, Japan, 480-1195
        • Recruiting
        • Aichi Medical University Hospital
        • Contact:
      • Seto-shi, Aichi, Japan, 489-8642
      • Toyoake-shi, Aichi, Japan, 470-1193
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8563
        • Recruiting
        • Hirosaki University School of Medicine & Hospital
        • Contact:
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Kashiwa-shi, Chiba, Japan, 277-8567
        • Recruiting
        • The Jikei University School of Medicine Kashiwa Hospital
        • Contact:
    • Ehime
      • Onsen-gun, Ehime, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital
        • Contact:
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
      • Fukuoka-shi, Fukuoka, Japan, 810-8563
      • Fukuoka-shi, Fukuoka, Japan, 811-1395
        • Recruiting
        • Kyusyu Cancer Center
        • Contact:
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital
        • Contact:
    • Gifu
      • Gifu-shi, Gifu, Japan, 501-1194
        • Recruiting
        • Gifu University Hospital
        • Contact:
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Recruiting
        • Gunma University Hospital
        • Contact:
      • Ōta, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center
        • Contact:
    • Hiroshima
      • Hatsukaichi-shi, Hiroshima, Japan, 738-8503
        • Recruiting
        • JA Hiroshima General Hospital
        • Contact:
      • Hiroshima-shi, Hiroshima, Japan, 730-8518
        • Recruiting
        • Hiroshima City Hiroshima Citizens Hospital
        • Contact:
      • Hiroshima-shi, Hiroshima, Japan, 734-8530
      • Miyoshi-shi, Hiroshima, Japan, 728-8502
        • Recruiting
        • Miyoshi Central Hospital
        • Contact:
    • Hokkaido
      • Hakodate-shi, Hokkaido, Japan, 041-8680
      • Sapporo-shi, Hokkaido, Japan, 060-0033
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospita
        • Contact:
    • Hyogo
      • Akashi-shi, Hyogo, Japan, 673-8558
        • Recruiting
        • Hyogo Cancer Center
        • Contact:
      • Amagasaki-shi, Hyogo, Japan, 660-8511
      • Himeji-shi, Hyogo, Japan, 670-8540
        • Recruiting
        • Japanese Red Cross Society Himeji Hospital
        • Contact:
    • Ibaraki
      • Tsukuba-shi, Ibaraki, Japan, 305-8576
        • Recruiting
        • University of Tsukuba Hospital
        • Contact:
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-8505
        • Recruiting
        • Iwate Medical University Hospital
        • Contact:
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 890-8520
      • Kagoshima-shi, Kagoshima, Japan, 890-8760
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan, 259-1143
        • Recruiting
        • Tokai University Hospital
        • Contact:
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Recruiting
        • St.Marianna University School of Medicine Hospital
        • Contact:
      • Sagamihara, Kanagawa, Japan, 252-0374
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center
        • Contact:
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
        • Contact:
      • Yokohama, Kanagawa, Japan, 236-0037
      • Yokohama-shi, Kanagawa, Japan, 240-8555
        • Recruiting
        • Yokohama Municipal Citizen's Hospital
        • Contact:
    • Kobe
      • Kobe-shi, Kobe, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital
        • Contact:
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital
        • Contact:
    • Kyoto
      • KYoto-shi, Kyoto, Japan, 605-0981
        • Recruiting
        • Japanese Red Cross Kyoto Daiichi Hospital
        • Contact:
    • Mie
      • Ise-shi, Mie, Japan, 516-8512
        • Recruiting
        • Ise Red Cross Hospital
        • Contact:
      • Matsuzaka, Mie, Japan, 515-8566
        • Recruiting
        • JA Matsuzaka Central Hospital
        • Contact:
      • Tsu, Mie, Japan, 514-8507
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Recruiting
        • Shinshu University Hospital
        • Contact:
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital
        • Contact:
    • Nagoya
      • Nagoya-shi, Nagoya, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center
        • Contact:
    • Nara
      • Nara-shi, Nara, Japan, 630-8581
        • Recruiting
        • Nara Prefecture General Medical Center
        • Contact:
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital
        • Contact:
      • Niigata-shi, Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical And Dental Hospital
        • Contact:
    • Oita
      • Yufu, Oita, Japan, 879-5593
        • Recruiting
        • Oita University Hospital
        • Contact:
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • Recruiting
        • Hospital University of the Ryukyus
        • Contact:
      • Tomishiro-shi, Okinawa, Japan, 901-0243
        • Recruiting
        • Tomishiro Central Hospital
        • Contact:
      • Uruma-shi, Okinawa, Japan, 904-2293
    • Osaka
      • Kaizuka, Osaka, Japan, 597-0015
      • Osaka-shi, Osaka, Japan, 537-8511
      • Osaka-shi, Osaka, Japan, 545-0051
      • Sakai, Osaka, Japan, 593-8304
      • Suita-shi, Osaka, Japan, 565-0871
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical College Hospital
        • Contact:
      • Ōsaka-sayama-shi, Osaka, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital
        • Contact:
    • Saitama
      • Hidaka-shi, Saitama, Japan, 350-1241
        • Recruiting
        • Saitama Medical University International Medical Center
        • Contact:
          • Keiichi Fujiwara
          • Phone Number: 81-42-984-4531
        • Contact:
          • fujiwara@saitama-med.ac.jp
      • Ina, Saitama, Japan, 362-0806
      • Koshigaya-shi, Saitama, Japan, 343-0023
        • Recruiting
        • Koshigaya Municipal Hospital
        • Contact:
      • Koshigaya-shi, Saitama, Japan, 343-8555
        • Recruiting
        • Dokkyo Medical University Saitama Medical Center
        • Contact:
      • Tokorozawa-shi, Saitama, Japan, 359-8513
        • Recruiting
        • National Defense Medical College Hospital
        • Contact:
      • Wako, Saitama, Japan, 351-0102
        • Recruiting
        • Saitama National Hospital
        • Contact:
    • Sapporo
      • Sapporo-shi, Sapporo, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital
        • Contact:
    • Shikoku
      • Matsuyama-shi, Shikoku, Japan, 791-0280
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
    • Shizuoka
      • Nagaizumi-chō, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center
        • Contact:
      • Shizuoka-shi, Shizuoka, Japan, 420-0853
        • Recruiting
        • Japanese Red Cross Shizuoka Hospital
        • Contact:
    • Tochgi
      • Mibu, Tochgi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital
        • Contact:
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Recruiting
        • Jichi Medical University Hospital
        • Contact:
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 770-8503
        • Recruiting
        • Tokushima University Hospital
        • Contact:
    • Tokyo
      • Arakawa, Tokyo, Japan, 116-8567
        • Recruiting
        • Tokyo Women's Medical University Medical Center East
        • Contact:
      • Bunkyō-Ku, Tokyo, Japan, 113-8510
        • Recruiting
        • Tokyo Medical And Dental University University Hospital of Medicine
        • Contact:
      • Bunkyō-Ku, Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
      • Bunkyō-Ku, Tokyo, Japan, 113-8655
        • Recruiting
        • The University of Tokyo Hospital
        • Contact:
      • Bunkyō-Ku, Tokyo, Japan, 113-8677
        • Recruiting
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
        • Contact:
      • Chiyoda, Tokyo, Japan, 101-0062
        • Recruiting
        • Sasaki Faundation Kyoundo Hospital
        • Contact:
      • Fuchu-shi, Tokyo, Japan, 183-8524
        • Recruiting
        • Tokyo Metropolitan Tama Medical Center
        • Contact:
      • Katsushika-ku, Tokyo, Japan, 125-8506
        • Recruiting
        • The Jikei University Katsushika Medical Center
        • Contact:
      • Komae-shi, Tokyo, Japan, 201-8601
        • Recruiting
        • The Jikei University Daisan Hospital
        • Contact:
      • Koto-Ku, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital
        • Contact:
      • Meguro-ku, Tokyo, Japan, 153-8515
      • Minato-ku, Tokyo, Japan, 105-8461
        • Recruiting
        • The Jikei University Hospital
        • Contact:
      • Shinjuku-Ku, Tokyo, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University Hospital
        • Contact:
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University Hospital
        • Contact:
      • Suginami, Tokyo, Japan, 166-0012
        • Recruiting
        • Kosei General Hospital
        • Contact:
      • Tachikawa-shi, Tokyo, Japan, 190-8531
    • Tottori
      • Tottori-shi, Tottori, Japan, 680-0901
        • Recruiting
        • Tottori Prefectural Central Hospital
        • Contact:
      • Yonago-shi, Tottori, Japan, 683-8504
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 990-9585
    • Yamaguchi
      • Shunan-shi, Yamaguchi, Japan, 745-8522
        • Recruiting
        • Tokuyama Central Hospital
        • Contact:
      • Yamaguchi-shi, Yamaguchi, Japan, 753-8519
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
      • Seoul, Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital
        • Contact:
    • Goyang
      • Ilsandong, Goyang, Korea, Republic of, 10408
    • Incheon
      • Namdong, Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
    • Seoul
      • Seocho, Seoul, Korea, Republic of, 137-040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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) 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:

  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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard therapy
combination of paclitaxel and carboplatin
Drug: adjuvant chemotherapy
combination of paclitaxel and carboplatin
Other Names:
  • paclitaxel and carboplatin
No Intervention: Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
  1. In surviving patients, cut off will be on the last date the patient is confirmed to be alive.
  2. 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.
From date of randomization until the date of death from any cause, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival
Time Frame: 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
  1. 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.
  2. Progression observed by CA-125 only shall not be handled as an event in this study.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japanese Gynecologic Oncology Group

Collaborators

Korean Gynecologic Oncology Group

Investigators

  • Study Chair: Hiroshi Tanabe, M.D., National Cancer Center Hospital East

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2012

Primary Completion (Anticipated)

October 1, 2029

Study Completion (Anticipated)

February 1, 2030

Study Registration Dates

First Submitted

August 16, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JGOG3020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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