Ongoing Trials – status update G-GOC LACC/G-GOC-1001 Ph III Laparoscopic or Robotic Radical Hysterectomy vs Abdominal Hysterectomy in Early Stage Cervical Cancer PI: Pedro Ramirez Trial setting: Cervix, FIGO stage IA1, IA2, or IB1 Study Design: Randomized Phase III Sponsor(s): None Planned No. of patients: 740 Current accrual: 610 as of 04/26/17 Other important information: 27 sites
G-GOC N=740 International Collaboration End points: DSF Recurrence rate Overall survival Treatment-related morbidity QOL Lymphatic mapping feasibility Total Sites: 27
G-GOC LACC Consort Statement as at 26 th April 2017 Assessed for Eligibility n= 1140 Excluded n = 530 Not meeting eligibility criteria (n = 275) Pending Refused (n = 192) n = 0 Other (n = 52) SHAPE Trial (n = 11) Randomised n = 610 Allocated to TARH Allocated to TLRH/TRRH n = 302 n = 308
G-GOC 100 120 140 160 180 200 220 240 260 280 300 320 340 360 380 400 420 440 460 480 500 520 540 560 580 600 620 640 660 20 40 60 80 Jan-08 0 Mar-08 May-08 Jul-08 3 Sep-08 Nov-08 4 Jan-09 Mar-09 May-09 6 Jul-09 7 Sep-09 Nov-09 Jan-10 8 Mar-10 May-10 9 Jul-10 11 Sep-10 Nov-10 Jan-11 12 Mar-11 May-11 Jul-11 13 Sep-11 14 As of April 26, 2017 Nov-11 15 19 Jan-12 Accrual to Date Mar-12 20 Recruitment Tracker May-12 21 22 Jul-12 Sep-12 23 Nov-12 Jan-13 Mar-13 May-13 Jul-13 Sep-13 24 Nov-13 Jan-14 Mar-14 May-14 Jul-14 Sep-14 Nov-14 Jan-15 27 Mar-15 May-15 Jul-15 Sep-15 Nov-15 Jan-16 Mar-16 May-16 Jul-16 Sep-16 28 Nov-16 Jan-17 Mar-17 32
G-GOC
Ongoing Trials – status update G-GOC ConCerv/G-GOC-1002 Kathleen M. Schmeler, MD Associate Professor Department of Gynecologic Oncology & Reproductive Medicine
G-GOC ConCerv/G-GOC-1002 Conservative Surgery for Women with Low-risk, Early Stage Cervical Cancer PI: Kathleen Schmeler Trial setting: Cervix, FIGO stages IA2 or IB1 Study Design: Phase II Sponsor(s): M.D. Anderson Cancer Center Planned No. of patients: 100 Current accrual: 73 Other important information:
G-GOC ConCerv/G-GOC-1002 Inclusion Criteria: • Squamous cell carcinoma of the cervix (any grade) or grade 1 or 2 adenocarcinoma of the cervix • FIGO stage IA2 or IB1 disease • Tumor diameter <2 cm on physical exam and on imaging studies • No lymphovascular space invasion (LVSI) present on biopsy or previous cone • Less than 10 mm of cervical stromal invasion • Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) CIN II, CIN III or adenocarcinoma-in- situ. (A negative margin is defined as no invasive cancer within 1.0mm of both the endocervical and ectocervical margins and no AIS or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted) • Imaging PET scan, CT scan of the abdomen and pelvis, and/or MRI of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment
G-GOC ConCerv/G-GOC-1002 • Future fertility desired: Cone biopsy and pelvic node dissection • Future fertility not desired: Simple hysterectomy and pelvic node dissection *SLN only optional
G-GOC ConCerv/G-GOC-1002 • Sample size: 100 evaluable patients • Stopping Rules: – Residual disease in the hysterectomy specimens of > 3 patients – If > 3 patients develop recurrent disease
G-GOC ConCerv/G-GOC-1002 • MD Anderson, USA (K. Schmeler) • IDC, Colombia (G. Rendon) • INCAN, Mexico (D. Cantu) • Barretos, Brazil (G. Fontes) • INEN, Peru (A. Lopez) • Instituto de Ginecologia, Argentina (M. Riege) • Hospital Italiano, Argentina (M. Perrota) • Royal Women’ s, Australia (O. McNally) • Nebraska Methodist, USA (D. Crotzer) • Hospital Britanico, Argentina (A. Maya) • Chulalongkorn University, Thailand (T. Manchana) • Hospital Erasto Gaertner, Brazil (A.Tsunoda) • Instituto Brasileiro Controle de Cancer
G-GOC ConCerv/G-GOC-1002 LACC Contacts Pedro T. Ramirez, MD peramire@mdanderson.org Vanessa Behan vanessa.behan@health.qld.gov.au ConCerv Contacts Kathleen M Schmeler kschmele@mdanderson.org Cindy Melendez cvmelend@mdanderson.org
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