Phase III Trial of Stage I Ovarian Cancer After Surgery

Epithelial Ovarian Cancer Clinical Trial

Official title:

Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063527
• Other study ID #: JGOG3020
• Status: Recruiting
• Phase: Phase 3
• Start date: July 20, 2012
• Est. completion date: February 1, 2030

Study information

• Verified date: August 2019
• Source: Japanese Gynecologic Oncology Group
• Contact: Hiroshi Tanabe, M.D.
• Phone: 81-4-7133-1111
• Email: htanabe[@]east.ncc.go.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: February 1, 2030
• Est. primary completion date: October 1, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• adjuvant chemotherapy
combination of paclitaxel and carboplatin

Locations

Country	Name	City	State
Japan	Hyogo Cancer Center	Akashi-shi	Hyogo
Japan	Kansai Rosai Hospital	Amagasaki-shi	Hyogo
Japan	Tokyo Women's Medical University Medical Center East	Arakawa	Tokyo
Japan	Nippon Medical School Hospital	Bunkyo-Ku	Tokyo
Japan	The University of Tokyo Hospital	Bunkyo-Ku	Tokyo
Japan	Tokyo Medical And Dental University University Hospital of Medicine	Bunkyo-Ku	Tokyo
Japan	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital	Bunkyo-Ku	Tokyo
Japan	Sasaki Faundation Kyoundo Hospital	Chiyoda	Tokyo
Japan	Tokyo Metropolitan Tama Medical Center	Fuchu-shi	Tokyo
Japan	Kyushu University Hospital	Fukuoka-shi	Fukuoka
Japan	Kyusyu Cancer Center	Fukuoka-shi	Fukuoka
Japan	Kyusyu Medical Center	Fukuoka-shi	Fukuoka
Japan	Gifu University Hospital	Gifu-shi	Gifu
Japan	Hospital Hakodate Hokkaido	Hakodate-shi	Hokkaido
Japan	JA Hiroshima General Hospital	Hatsukaichi-shi	Hiroshima
Japan	Saitama Medical University International Medical Center	Hidaka-shi	Saitama
Japan	Japanese Red Cross Society Himeji Hospital	Himeji-shi	Hyogo
Japan	Hirosaki University School of Medicine & Hospital	Hirosaki-shi	Aomori
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima-shi	Hiroshima
Japan	Hiroshima Prefectural Hospital	Hiroshima-shi	Hiroshima
Japan	Saitama Cancer Center	Ina	Saitama
Japan	Ise Red Cross Hospital	Ise-shi	Mie
Japan	Tokai University Hospital	Isehara-shi	Kanagawa
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Kagoshima City Hospital	Kagoshima-shi	Kagoshima
Japan	Kagoshima University Medical And Dental Hospital	Kagoshima-shi	Kagoshima
Japan	Kaizuka City Hospital	Kaizuka	Osaka
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	The Jikei University School of Medicine Kashiwa Hospital	Kashiwa-shi	Chiba
Japan	The Jikei University Katsushika Medical Center	Katsushika-ku	Tokyo
Japan	St.Marianna University School of Medicine Hospital	Kawasaki-shi	Kanagawa
Japan	Kobe City Medical Center General Hospital	Kobe-shi	Kobe
Japan	The Jikei University Daisan Hospital	Komae-shi	Tokyo
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya-shi	Saitama
Japan	Koshigaya Municipal Hospital	Koshigaya-shi	Saitama
Japan	The Cancer Institute Hospital	Koto-Ku	Tokyo
Japan	Kumamoto University Hospital	Kumamoto-shi	Kumamoto
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	Japanese Red Cross Kyoto Daiichi Hospital	KYoto-shi	Kyoto
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Shinshu University Hospital	Matsumoto-shi	Nagano
Japan	Shikoku Cancer Center	Matsuyama-shi	Shikoku
Japan	JA Matsuzaka Central Hospital	Matsuzaka	Mie
Japan	Toho University Ohashi Medical Center	Meguro-ku	Tokyo
Japan	Dokkyo Medical University Hospital	Mibu	Tochgi
Japan	The Jikei University Hospital	Minato-ku	Tokyo
Japan	Miyoshi Central Hospital	Miyoshi-shi	Hiroshima
Japan	Iwate Medical University Hospital	Morioka-shi	Iwate
Japan	Shizuoka Cancer Center	Nagaizumi-cho	Shizuoka
Japan	Aichi Medical University Hospital	Nagakute-shi	Aichi
Japan	Nagano Municipal Hospital	Nagano
Japan	Saiseikai Nagasaki Hospital	Nagasaki
Japan	Nagasaki University Hospital	Nagasaki-shi	Nagasaki
Japan	Aichi Cancer Center	Nagoya-shi	Nagoya
Japan	Hospital University of the Ryukyus	Nakagami-gun	Okinawa
Japan	Nara Prefecture General Medical Center	Nara-shi	Nara
Japan	Niigata Cancer Center Hospital	Niigata-shi	Niigata
Japan	Niigata University Medical and Dental Hospital	Niigata-shi	Niigata
Japan	Ehime University Hospital	Onsen-gun	Ehime
Japan	Kindai University Hospital	Osaka-sayama-shi	Osaka
Japan	Osaka City University Hospital	Osaka-shi	Osaka
Japan	Osaka International Cancer Center	Osaka-shi	Osaka
Japan	Gunma Prefectural Cancer Center	Ota	Gunma
Japan	Saga University Hospital	Saga
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Jichi Medical University Saitama Medical Center	Saitama
Japan	Sakai City Medical Center	Sakai	Osaka
Japan	Hokkaido University Hospita	Sapporo-shi	Hokkaido
Japan	JA Sapporo-Kosei general Hospital	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital	Sapporo-shi	Sapporo
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Tosei General Hospital	Seto-shi	Aichi
Japan	Jichi Medical University Hospital	Shimotsuke-shi	Tochigi
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-Ku	Tokyo
Japan	Japanese Red Cross Shizuoka Hospital	Shizuoka-shi	Shizuoka
Japan	Tokuyama Central Hospital	Shunan-shi	Yamaguchi
Japan	Kosei General Hospital	Suginami	Tokyo
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Tachikawa Hospital	Tachikawa-shi	Tokyo
Japan	Osaka Medical College Hospital	Takatsuki-shi	Osaka
Japan	National Defense Medical College Hospital	Tokorozawa-shi	Saitama
Japan	Tokushima University Hospital	Tokushima-shi	Tokushima
Japan	Tomishiro Central Hospital	Tomishiro-shi	Okinawa
Japan	Tottori Prefectural Central Hospital	Tottori-shi	Tottori
Japan	Fujita Health University Hospital	Toyoake-shi	Aichi
Japan	Mie University Hospital	Tsu	Mie
Japan	University of Tsukuba Hospital	Tsukuba-shi	Ibaraki
Japan	Okinawa Prefectural Chubu Hospital	Uruma-shi	Okinawa
Japan	Saitama National Hospital	Wako	Saitama
Japan	Yamagata University Hospital	Yamagata-shi	Yamagata
Japan	Yamaguchi Red Cross Hospital	Yamaguchi-shi	Yamaguchi
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa
Japan	Yokohama City University Hospital	Yokohama	Kanagawa
Japan	Yokohama Minami Kyosai Hospital	Yokohama	Kanagawa
Japan	Yokohama Municipal Citizen's Hospital	Yokohama-shi	Kanagawa
Japan	Tottori University Hospital	Yonago-shi	Tottori
Japan	Oita University Hospital	Yufu	Oita
Korea, Republic of	National Cancer Center	Ilsandong	Goyang
Korea, Republic of	Gachon University Gil Medical Center	Namdong	Incheon
Korea, Republic of	Seoul ST' Mary's Hospital	Seocho	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Japanese Gynecologic Oncology Group	Korean Gynecologic Oncology Group

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	In surviving patients, cut off will be on the last date the patient is confirmed to be alive.; 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	Relapse-free survival	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.; 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