Phase III Trial of Stage I Ovarian Cancer After Surgery
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- Drug: adjuvant chemotherapy
- Registration Number
- NCT04063527
- Lead Sponsor
- Japanese Gynecologic Oncology Group
- Brief Summary
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 360
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard therapy adjuvant chemotherapy combination of paclitaxel and carboplatin
- Primary Outcome Measures
Name Time Method Overall survival 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (103)
Tokyo Metropolitan Tama Medical Center
🇯🇵Fuchu-shi, Tokyo, Japan
Sasaki Faundation Kyoundo Hospital
🇯🇵Chiyoda, Tokyo, Japan
Tokyo Medical And Dental University University Hospital of Medicine
🇯🇵Bunkyō-Ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
The Cancer Institute Hospital
🇯🇵Koto-Ku, Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Toho University Ohashi Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Tokyo Women's Medical University Medical Center East
🇯🇵Arakawa, Tokyo, Japan
The University of Tokyo Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
Tottori Prefectural Central Hospital
🇯🇵Tottori-shi, Tottori, Japan
The Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
Kosei General Hospital
🇯🇵Suginami, Tokyo, Japan
Tokuyama Central Hospital
🇯🇵Shunan-shi, Yamaguchi, Japan
Tachikawa Hospital
🇯🇵Tachikawa-shi, Tokyo, Japan
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Seoul ST' Mary's Hospital
🇰🇷Seocho, Seoul, Korea, Republic of
Saiseikai Nagasaki Hospital
🇯🇵Nagasaki, Japan
National Cancer Center
🇰🇷Ilsandong, Goyang, Korea, Republic of
Gifu University Hospital
🇯🇵Gifu-shi, Gifu, Japan
Hirosaki University School of Medicine & Hospital
🇯🇵Hirosaki-shi, Aomori, Japan
Kyusyu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
Gunma Prefectural Cancer Center
🇯🇵Ōta, Gunma, Japan
Hospital Hakodate Hokkaido
🇯🇵Hakodate-shi, Hokkaido, Japan
Miyoshi Central Hospital
🇯🇵Miyoshi-shi, Hiroshima, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba-shi, Ibaraki, Japan
Tokai University Hospital
🇯🇵Isehara-shi, Kanagawa, Japan
JA Matsuzaka Central Hospital
🇯🇵Matsuzaka, Mie, Japan
Kumamoto University Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Nara Prefecture General Medical Center
🇯🇵Nara-shi, Nara, Japan
Osaka Medical College Hospital
🇯🇵Takatsuki-shi, Osaka, Japan
Osaka International Cancer Center
🇯🇵Osaka-shi, Osaka, Japan
Dokkyo Medical University Saitama Medical Center
🇯🇵Koshigaya-shi, Saitama, Japan
Okinawa Prefectural Chubu Hospital
🇯🇵Uruma-shi, Okinawa, Japan
Shimane University Hospital
🇯🇵Izumo, Shimane, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
JA Sapporo-Kosei general Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Hokkaido University Hospita
🇯🇵Sapporo-shi, Hokkaido, Japan
Kansai Rosai Hospital
🇯🇵Amagasaki-shi, Hyogo, Japan
Japanese Red Cross Society Himeji Hospital
🇯🇵Himeji-shi, Hyogo, Japan
Kagoshima City Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Iwate Medical University Hospital
🇯🇵Morioka-shi, Iwate, Japan
Yokohama Municipal Citizen's Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Kitasato University Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe-shi, Kobe, Japan
Japanese Red Cross Kyoto Daiichi Hospital
🇯🇵KYoto-shi, Kyoto, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata-shi, Niigata, Japan
Hospital University of the Ryukyus
🇯🇵Nakagami-gun, Okinawa, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata-shi, Niigata, Japan
Tomishiro Central Hospital
🇯🇵Tomishiro-shi, Okinawa, Japan
Kaizuka City Hospital
🇯🇵Kaizuka, Osaka, Japan
Sakai City Medical Center
🇯🇵Sakai, Osaka, Japan
Osaka University Hospital
🇯🇵Suita-shi, Osaka, Japan
Dokkyo Medical University Hospital
🇯🇵Mibu, Tochgi, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke-shi, Tochigi, Japan
Tokushima University Hospital
🇯🇵Tokushima-shi, Tokushima, Japan
Yamagata University Hospital
🇯🇵Yamagata-shi, Yamagata, Japan
Tottori University Hospital
🇯🇵Yonago-shi, Tottori, Japan
Yamaguchi Red Cross Hospital
🇯🇵Yamaguchi-shi, Yamaguchi, Japan
Nagano Municipal Hospital
🇯🇵Nagano, Japan
Saga University Hospital
🇯🇵Saga, Japan
Jichi Medical University Saitama Medical Center
🇯🇵Saitama, Japan
Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Jikei University School of Medicine Kashiwa Hospital
🇯🇵Kashiwa-shi, Chiba, Japan
Kyusyu Medical Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
Ehime University Hospital
🇯🇵Onsen-gun, Ehime, Japan
JA Hiroshima General Hospital
🇯🇵Hatsukaichi-shi, Hiroshima, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Hyogo Cancer Center
🇯🇵Akashi-shi, Hyogo, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
St.Marianna University School of Medicine Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Kagoshima University Medical And Dental Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Yokohama Minami Kyosai Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
Nagasaki University Hospital
🇯🇵Nagasaki-shi, Nagasaki, Japan
Shinshu University Hospital
🇯🇵Matsumoto-shi, Nagano, Japan
Aichi Cancer Center
🇯🇵Nagoya-shi, Nagoya, Japan
Oita University Hospital
🇯🇵Yufu, Oita, Japan
Osaka City University Hospital
🇯🇵Osaka-shi, Osaka, Japan
Koshigaya Municipal Hospital
🇯🇵Koshigaya-shi, Saitama, Japan
Saitama Cancer Center
🇯🇵Ina, Saitama, Japan
Kindai University Hospital
🇯🇵Ōsaka-sayama-shi, Osaka, Japan
Saitama National Hospital
🇯🇵Wako, Saitama, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi-chō, Shizuoka, Japan
Nippon Medical School Hospital
🇯🇵Bunkyō-Ku, Tokyo, Japan
The Jikei University Katsushika Medical Center
🇯🇵Katsushika-ku, Tokyo, Japan
The Jikei University Daisan Hospital
🇯🇵Komae-shi, Tokyo, Japan
Gachon University Gil Medical Center
🇰🇷Namdong, Incheon, Korea, Republic of
Tosei General Hospital
🇯🇵Seto-shi, Aichi, Japan
Ise Red Cross Hospital
🇯🇵Ise-shi, Mie, Japan
Mie University Hospital
🇯🇵Tsu, Mie, Japan
Shikoku Cancer Center
🇯🇵Matsuyama-shi, Shikoku, Japan
Aichi Medical University Hospital
🇯🇵Nagakute-shi, Aichi, Japan
National Defense Medical College Hospital
🇯🇵Tokorozawa-shi, Saitama, Japan
Fujita Health University Hospital
🇯🇵Toyoake-shi, Aichi, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka-shi, Saitama, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo-shi, Sapporo, Japan
Japanese Red Cross Shizuoka Hospital
🇯🇵Shizuoka-shi, Shizuoka, Japan