Clinical trial NCT04063527: Phase III Trial of Stage I Ovarian Cancer After Surgery
Official title: Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Keywords: epithelial ovarian cancer
FIGO stage I
staging surgery
adjuvant chemotherapy
Lead sponsor: Japanese Gynecologic Oncology Group
Sponsor class: OTHER
Collaborators: name: Korean Gynecologic Oncology Group
First posted: 2019-08-21
Enrollment: 360
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary outcomes:
measure: Relapse-free survival
timeFrame: 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
Other outcomes:
Locations:
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Seto-shi
country: Japan
facility: Tosei General Hospital
state: Aichi
city: Toyoake-shi
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University School of Medicine & Hospital
state: Aomori
city: Kashiwa-shi
country: Japan
facility: The Jikei University School of Medicine Kashiwa Hospital
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Onsen-gun
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyusyu Medical Center
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyusyu Cancer Center
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Ōta
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Hatsukaichi-shi
country: Japan
facility: JA Hiroshima General Hospital
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima Prefectural Hospital
state: Hiroshima
city: Miyoshi-shi
country: Japan
facility: Miyoshi Central Hospital
state: Hiroshima
city: Hakodate-shi
country: Japan
facility: Hospital Hakodate Hokkaido
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: JA Sapporo-Kosei general Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospita
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Amagasaki-shi
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Himeji-shi
country: Japan
facility: Japanese Red Cross Society Himeji Hospital
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Medical And Dental Hospital
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Kagoshima City Hospital
state: Kagoshima
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: St.Marianna University School of Medicine Hospital
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizen's Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Minami Kyosai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Kobe
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: KYoto-shi
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hospital
state: Kyoto
city: Ise-shi
country: Japan
facility: Ise Red Cross Hospital
state: Mie
city: Matsuzaka
country: Japan
facility: JA Matsuzaka Central Hospital
state: Mie
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Nagoya
city: Nara-shi
country: Japan
facility: Nara Prefecture General Medical Center
state: Nara
city: Niigata-shi
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Yufu
country: Japan
facility: Oita University Hospital
state: Oita
city: Nakagami-gun
country: Japan
facility: Hospital University of the Ryukyus
state: Okinawa
city: Tomishiro-shi
country: Japan
facility: Tomishiro Central Hospital
state: Okinawa
city: Uruma-shi
country: Japan
facility: Okinawa Prefectural Chubu Hospital
state: Okinawa
city: Kaizuka
country: Japan
facility: Kaizuka City Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Center
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Sakai
country: Japan
facility: Sakai City Medical Center
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Ōsaka-sayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Ina
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Koshigaya-shi
country: Japan
facility: Koshigaya Municipal Hospital
state: Saitama
city: Koshigaya-shi
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
state: Saitama
city: Tokorozawa-shi
country: Japan
facility: National Defense Medical College Hospital
state: Saitama
city: Wako
country: Japan
facility: Saitama National Hospital
state: Saitama
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital
state: Sapporo
city: Matsuyama-shi
country: Japan
facility: Shikoku Cancer Center
state: Shikoku
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Nagaizumi-chō
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Shizuoka-shi
country: Japan
facility: Japanese Red Cross Shizuoka Hospital
state: Shizuoka
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochgi
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital
state: Tokushima
city: Arakawa
country: Japan
facility: Tokyo Women's Medical University Medical Center East
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: Tokyo Medical And Dental University University Hospital of Medicine
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
state: Tokyo
city: Chiyoda
country: Japan
facility: Sasaki Faundation Kyoundo Hospital
state: Tokyo
city: Fuchu-shi
country: Japan
facility: Tokyo Metropolitan Tama Medical Center
state: Tokyo
city: Katsushika-ku
country: Japan
facility: The Jikei University Katsushika Medical Center
state: Tokyo
city: Komae-shi
country: Japan
facility: The Jikei University Daisan Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Suginami
country: Japan
facility: Kosei General Hospital
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Tachikawa Hospital
state: Tokyo
city: Tottori-shi
country: Japan
facility: Tottori Prefectural Central Hospital
state: Tottori
city: Yonago-shi
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital
state: Yamagata
city: Shunan-shi
country: Japan
facility: Tokuyama Central Hospital
state: Yamaguchi
city: Yamaguchi-shi
country: Japan
facility: Yamaguchi Red Cross Hospital
state: Yamaguchi
city: Nagano
country: Japan
facility: Nagano Municipal Hospital
city: Nagasaki
country: Japan
facility: Saiseikai Nagasaki Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Saitama
country: Japan
facility: Jichi Medical University Saitama Medical Center
city: Ilsandong
country: Korea, Republic of
facility: National Cancer Center
state: Goyang
city: Namdong
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon
city: Seocho
country: Korea, Republic of
facility: Seoul ST' Mary's Hospital
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: National Cancer Center Hospital East
name: Hiroshi Tanabe, M.D.
role: STUDY_CHAIR
References: