Phase III Trial of Stage I Ovarian Cancer After Surgery
Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery
1 other identifier
interventional
360
2 countries
103
Brief Summary
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2012
Longer than P75 for phase_3
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2012
CompletedFirst Submitted
Initial submission to the registry
August 16, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
August 30, 2019
August 1, 2019
17.2 years
August 16, 2019
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
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 Outcomes (1)
Relapse-free survival
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
Study Arms (2)
Standard therapy
ACTIVE COMPARATORcombination of paclitaxel and carboplatin
Observation
NO INTERVENTIONObservation
Interventions
combination of paclitaxel and carboplatin
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (103)
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, 480-1195, Japan
Tosei General Hospital
Seto-shi, Aichi-ken, 489-8642, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1193, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, 036-8563, Japan
The Jikei University School of Medicine Kashiwa Hospital
Kashiwa-shi, Chiba, 277-8567, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
Ehime University Hospital
Onsen-gun, Ehime, 791-0295, Japan
Kyusyu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
Kyusyu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Gifu University Hospital
Gifu, Gifu, 501-1194, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550, Japan
JA Hiroshima General Hospital
Hatsukaichi-shi, Hiroshima, 738-8503, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, 730-8518, Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530, Japan
Miyoshi Central Hospital
Miyoshi-shi, Hiroshima, 728-8502, Japan
Hospital Hakodate Hokkaido
Hakodate-shi, Hokkaido, 041-8680, Japan
JA Sapporo-Kosei general Hospital
Sapporo, Hokkaido, 060-0033, Japan
Hokkaido University Hospita
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558, Japan
Kansai Rosai Hospital
Amagasaki-shi, Hyōgo, 660-8511, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyōgo, 670-8540, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Kagoshima University Medical And Dental Hospital
Kagoshima, Kagoshima-ken, 890-8520, Japan
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, 890-8760, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, 259-1143, Japan
St.Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0374, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
Yokohama Minami Kyosai Hospital
Yokohama, Kanagawa, 236-0037, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, 240-8555, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Kobe City Medical Center General Hospital
Kobe, Kobe, 650-0047, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556, Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, Kyoto, 605-0981, Japan
Ise Red Cross Hospital
Ise-shi, Mie-ken, 516-8512, Japan
JA Matsuzaka Central Hospital
Matsuzaka, Mie-ken, 515-8566, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Shinshu University Hospital
Matsumoto-shi, Nagano, 390-8621, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Aichi Cancer Center
Nagoya, Nagoya, 464-8681, Japan
Nara Prefecture General Medical Center
Nara, Nara, 630-8581, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Oita University Hospital
Yufu, Oita Prefecture, 879-5593, Japan
Hospital University of the Ryukyus
Nakagami-gun, Okinawa, 903-0215, Japan
Tomishiro Central Hospital
Tomishiro-shi, Okinawa, 901-0243, Japan
Okinawa Prefectural Chubu Hospital
Uruma, Okinawa, 904-2293, Japan
Kaizuka City Hospital
Kaizuka, Osaka, 597-0015, Japan
Osaka International Cancer Center
Osaka, Osaka, 537-8511, Japan
Osaka City University Hospital
Osaka, Osaka, 545-0051, Japan
Kindai University Hospital
Ōsaka-sayama-shi, Osaka, 589-8511, Japan
Sakai City Medical Center
Sakai, Osaka, 593-8304, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
Osaka Medical College Hospital
Takatsuki-shi, Osaka, 569-8686, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, 350-1241, Japan
Koshigaya Municipal Hospital
Koshigaya-shi, Saitama, 343-0023, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, 343-8555, Japan
Saitama Cancer Center
Shinden, Saitama, 362-0806, Japan
National Defense Medical College Hospital
Tokorozawa-shi, Saitama, 359-8513, Japan
Saitama National Hospital
Wako, Saitama, 351-0102, Japan
Sapporo Medical University Hospital
Sapporo, Sapporo, 060-8543, Japan
Shikoku Cancer Center
Matsuyama, Shikoku, 791-0280, Japan
Shimane University Hospital
Izumo, Shimane, 693-8501, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, 411-8777, Japan
Japanese Red Cross Shizuoka Hospital
Shizuoka, Shizuoka, 420-0853, Japan
Dokkyo Medical University Hospital
Mibu, Tochgi, 321-0293, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Tokyo Women's Medical University Medical Center East
Arakawa City, Tokyo, 116-8567, Japan
Tokyo Medical And Dental University University Hospital of Medicine
Bunkyō-Ku, Tokyo, 113-8510, Japan
Nippon Medical School Hospital
Bunkyō-Ku, Tokyo, 113-8603, Japan
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8655, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, 113-8677, Japan
Sasaki Faundation Kyoundo Hospital
Chiyoda City, Tokyo, 101-0062, Japan
Tokyo Metropolitan Tama Medical Center
Fuchu-shi, Tokyo, 183-8524, Japan
The Jikei University Katsushika Medical Center
Katsushika-ku, Tokyo, 125-8506, Japan
The Jikei University Daisan Hospital
Komae-shi, Tokyo, 201-8601, Japan
The Cancer Institute Hospital
Koto-Ku, Tokyo, 135-8550, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, 153-8515, Japan
The Jikei University Hospital
Minato-ku, Tokyo, 105-8461, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666, Japan
Kosei General Hospital
Suginami, Tokyo, 166-0012, Japan
Tachikawa Hospital
Tachikawa-shi, Tokyo, 190-8531, Japan
Tottori Prefectural Central Hospital
Tottori-shi, Tottori, 680-0901, Japan
Tottori University Hospital
Yonago-shi, Tottori, 683-8504, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
Tokuyama Central Hospital
Shunan-shi, Yamaguchi, 745-8522, Japan
Yamaguchi Red Cross Hospital
Yamaguchi, Yamaguchi, 753-8519, Japan
Nagano Municipal Hospital
Nagano, 381-8551, Japan
Saiseikai Nagasaki Hospital
Nagasaki, 850-0003, Japan
Saga University Hospital
Saga, 849-8501, Japan
Jichi Medical University Saitama Medical Center
Saitama, 330-8503, Japan
National Cancer Center
Ilsandong, Goyang, 10408, South Korea
Gachon University Gil Medical Center
Namdong, Incheon, 21565, South Korea
Seoul ST' Mary's Hospital
Seocho, Seoul, 137-040, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital
Seoul, 03722, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hiroshi Tanabe, M.D.
National Cancer Center Hospital East
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2019
First Posted
August 21, 2019
Study Start
July 20, 2012
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
February 1, 2030
Last Updated
August 30, 2019
Record last verified: 2019-08