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G-GOC LACC/G-GOC-1001 Ph III Laparoscopic or Robotic Radical - - PowerPoint PPT Presentation
G-GOC LACC/G-GOC-1001 Ph III Laparoscopic or Robotic Radical - - PowerPoint PPT Presentation
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
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G-GOC
LACC Consort Statement as at 26th April 2017
Assessed for Eligibility n= 1140 Randomised n = 610 Allocated to TARH n = 302 Allocated to TLRH/TRRH n = 308 Excluded n = 530 Not meeting eligibility criteria (n = 275) Refused (n = 192) Other (n = 52) SHAPE Trial (n = 11) Pending n = 0
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G-GOC
Recruitment Tracker 24 23 22 21 20 19 15 14 13 12 11 9 8 7 6 4 3 28 27 20 40 60 80 100 120 140 160 180 200 220 240 260 280 300 320 340 360 380 400 420 440 460 480 500 520 540 560 580 600 620 640 660
Jan-08 Mar-08 May-08 Jul-08 Sep-08 Nov-08 Jan-09 Mar-09 May-09 Jul-09 Sep-09 Nov-09 Jan-10 Mar-10 May-10 Jul-10 Sep-10 Nov-10 Jan-11 Mar-11 May-11 Jul-11 Sep-11 Nov-11 Jan-12 Mar-12 May-12 Jul-12 Sep-12 Nov-12 Jan-13 Mar-13 May-13 Jul-13 Sep-13 Nov-13 Jan-14 Mar-14 May-14 Jul-14 Sep-14 Nov-14 Jan-15 Mar-15 May-15 Jul-15 Sep-15 Nov-15 Jan-16 Mar-16 May-16 Jul-16 Sep-16 Nov-16 Jan-17 Mar-17
32
Accrual to Date As of April 26, 2017
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G-GOC
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ConCerv/G-GOC-1002
Ongoing Trials – status update
G-GOC
Kathleen M. Schmeler, MD Associate Professor Department of Gynecologic Oncology & Reproductive Medicine
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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
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ConCerv/G-GOC-1002
G-GOC
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
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ConCerv/G-GOC-1002
G-GOC
- Future fertility desired:
Cone biopsy and pelvic node dissection
- Future fertility not desired:
Simple hysterectomy and pelvic node dissection *SLN only optional
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ConCerv/G-GOC-1002
G-GOC
- Sample size: 100 evaluable patients
- Stopping Rules:
– Residual disease in the hysterectomy specimens of > 3 patients – If > 3 patients develop recurrent disease
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ConCerv/G-GOC-1002
G-GOC
- 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
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