JGOG3020 Japanese Gynecologic Oncology Group A pha hase I III r - - PowerPoint PPT Presentation

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JGOG3020

JGOG Ovarian committee JGOG3020 Principal investigator

• Dep. OB/GYN Jikei University School of Medicine, Tokyo, Japan

Hiroshi Tanabe

Japanese Gynecologic Oncology Group

ＪＧＯＧ３０２０

Staging surgery Ovarian Cancer FIGO stage I 230 cases

TC or DC 3～6 cycle

230 cases

R A N D O M I Z E

Observation

Primary Endpoint：OS Non-inferiority study

Staging surgery: TAH,BSO,OMTX, Peritoneal washings for cytology pelvic and aortic node dissections peritoneal biopsies Eligible ・Stage IA: grade 2/3, clear cell ・Stage IB: grade 2/3, clear cell ・Stage IC1 Exclusive: Stage IC2, IC3 PTX:175mg/m2, CBDCA: AUC=6 DTX: 70mg/m2, CBDCA: AUC=6

EORTC-ACTION

Staging surgery (n=151) Non Staging surgery (n=295) Observation (n=75) Chemotherapy (n=76) Observation (n=147) Chemotherapy (n=148) Overall Logrank test P=0.6535 Overall Logrank test P=0.0329 5y OS：85% 5y OS：85% 5y OS：73% 5y OS：85%

Around 11% of T1 shows lymph node metastasis Is the adjuvant chemotherapy really necessary for stage I epithelial ovarian cancer with staging surgery?

There is a strong evidence that optimal surgical staging identifies patients have either little or nothing to gain from adjuvant chemotherapy (The Cochrane Collaboration).

ＪＧＯＧ３０２０

Staging surgery Ovarian Cancer FIGO stage I 230 cases

TC or DC 3～6 cycle

230 cases

R A N D O M I Z E

Observation

Primary Endpoint：OS Non-inferiority study

Staging surgery: TAH,BSO,OMTX, Peritoneal washings for cytology pelvic and aortic node dissections peritoneal biopsies Eligible ・Stage IA: grade 2/3, clear cell ・Stage IB: grade 2/3, clear cell ・Stage IC1 Exclusive: Stage IC2, IC3 PTX:175mg/m2, CBDCA: AUC=6 DTX: 70mg/m2, CBDCA: AUC=6 GOG finally concluded, the adjuvant chemotherapy of more than TC3 cycle shows to be not necessary.

Results of JGOG questionnaire

50 100 150 200 250 300 350

IC(a),(1),(2) Performed Lymphadenectomy Peritoneal biopsy Informed consent Eligible for 3020 sub-stage FIGO stage I IA/Ib G1 Agree and entry

2014/11～2015/4

Protocol Amendment and Future

• Peritoneal biopsies is recommended, but it is

not indispensable if evaluation is enough

• Expected number of subjects: 640→460 patients

Recruitment period: 5→12 years (to June 2024) Follow-up period: 5 years Total study duration: 10→17 years

• International collaboration

KGOG, TGOG

Economical Merit

Cost of treatment per year for EOC stage I ・Adjuvant chemotherapy group：￥2,760,000 （n=15, 2012） ・Follow-up group：￥1,400,000 （n=5, 2012）

（２,７６０,００0－１,４０0,000）×2000Pt.=

￥2,720,000,000 ($24,200,000)