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GCIG Cervix Committee: Prague 2010

GCIG Cervix Committee: Prague 2010. William Small Jr. Satoru Sagae. Activity Since Chicago. Conference calls were held in July and September Separate radiotherapy calls were accomplished to finalize the radiotherapy section for the upcoming ANZGOG outback trial.

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GCIG Cervix Committee: Prague 2010

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  1. GCIG Cervix Committee: Prague 2010 William Small Jr. Satoru Sagae

  2. Activity Since Chicago • Conference calls were held in July and September • Separate radiotherapy calls were accomplished to finalize the radiotherapy section for the upcoming ANZGOG outback trial. • Significant progress was made on completing open trials and developing concepts.

  3. Publications/Presentations Kitchener H.C., Thomas G., Hoskins W., Small W. Jr., Trimble, E.L. on behalf of the Cervical Cancer Consensus Group.  The Development of Priority Cervical Cancer Trials: A Gynecologic Cancer InterGroup Report.  Int J Gyn Can, 20(6):1092-1100, August 2010. Viswanathan, A.N., Creutzberg, C., Craighead, P., McCormack, M., Toita, T., Narayan, K., Reed, N., Long, H., Kim, H.J., Marth, C., Lindegaard, J., Cerrotta, A., Small, W Jr., Trimble, E. Brachytherapy Practice Patterns in the Gynecologic Cancer Intergroup. In Press, Int J Radiol Oncol Biol Phys, 2010.

  4. ACTIVE GCIC TRIALS

  5. S-1+CDDP vs single agent CDDP Phase3 study in Cervical cancer (IVB/Rec)Patient enrollment status (01/Jun/2010) Japan: 151 / 200 pts (75.5%)Korea: 71 / 100 pts (71.0%)Taiwan: 32 / 60 pts (53.3%) Total: 254 / 360 pts (70.3%) Arm SP: 126ptsArm P: 128pts(not treated: 7pts)

  6. JGOGDT-104/GCIG S-1 Trial Accrual Total 338 Japan 208, Korea 86, Taiwan 44

  7. GOG 240(GOG 204 Replacement) • 2 x 2 Factorial Design • First randomization: Winner of GOG 204 (Cisplatin + Paclitaxel) vs Topotecan + Paclitaxel • Second Randomization: Bevacizumab vs No Bevacizumab • Primary Endpoint = survival, superiority trial (30% reduction in HR) • Accrual Goal = 450 patients KS Tewari Study Chair

  8. GOG 263 Randomized Phase III Clinical Trial of Adjuvant Radiation vs Chemoradiation In Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy Sang Young Ryu, M.D. Korea Cancer Center Hospital Seoul, Korea

  9. GOG 263 Control Arm; Radiation therapy Randomization Cervical cancer Stage I-IIA Radical hysterectomy+BPLND >2 of intermediate risk factors CRT Arm; Weekly CDDP 40mg/m2concurrent to radiation

  10. RTOG-0724 (GOG): ChemoRT with and without adjuvant chemotherapy in high risk cervix cancer after hysterectomy

  11. Developing Concepts – Discussions

  12. THE OUTBACK TRIAL A Phase III trial of adjuvant chemotherapy following chemo-radiation as primary treatment for locally advanced cervical cancer compared to chemo-radiation alone

  13. Design: International randomized phase III study

  14. Countries that have expressed interest

  15. Timelines • Lead HREC approval: Aug 2010 - administrative amendment just approved • CTEP approval of concept: Aug 2010 • CRFs finalized: Sept 2010 - database development in process • First ANZ site open: Dec 2010 • First patient on study: Dec 2010 • Last patient on study: Dec 2014 • Follow-up completed: Dec 2019

  16. the SHAPE Trial: Simple Hysterectomy And Pelvic node dissection in Early cervix cancerComparing radical hysterectomy and pelvic node dissection against simple hysterectomy and pelvic node dissection in patients with low risk cervical cancer Chair: Marie Plante Laval University, Quebec City An NCIC Clinical Trials Group proposal for the Gynecological Cancer Inter Group (GCIG) Prague - October 2010

  17. SHAPE trial • Low risk disease • < 2cm & < 50% stromal invasion • Risk of parametrial infiltration < 1% • Less radical surgery (simple hyst + nodes) may be be adequate treatment • < 5% pelvic relapse rate • Success of salvage therapy in 65% (RT/SX) • Overall survival should not be compromised • Background • Rad hyst/nodes: standard treatment • Acute/long term side effects: 20-30%

  18. SHAPE trial • Objective: • To show that simple hysterectomy in low risk cervix cancer is safe and is associated with less morbidity than radical surgery • AND that overall survival will not be significantly different (between RHPND and SHPND) even if a slightly higher relapse rate occurs in the latter group • Primary endpoint • Compare the 3-year pelvic recurrence rate between radical and simple hysterectomy patients

  19. Patient Population Stage IA2-IB1 Cervix cancer Squamous , Adeno & Adenosquamous ca < 2cm and < 50% stromal invasion Grades 1,2 & 3 MRI/ CT node negative RANDOMIZATION Stratification Centers (performing SN mapping vs not) Mode of surgery (abd vs non-abd route) Stage (IA2 vs IB1) Histology (squamous vs adenoca) Grade (1-2 vs 3) Control Arm Radical Hysterectomy & PLND* +/- SLN Mapping** Experimental Arm Simple Hysterectomy with Upper Vaginectomy & PLND* +/- SLN Mapping** Post surgical quality of life & disease outcomes measured 3 monthly X 2 years, and 6 monthly for further 3 years * PLND – Pelvic lymph node dissection **SLN - Sentinel lymph node mapping optional

  20. the SHAPE Trial: International collaborators Co-op groupsSpecialty groups AGO-Austria Belarus AGO-Germany Czech Republic ANZGOG-Australia Latria GEICO-Spain Lithuania MRC/NCRI-England Romania NSGO-Scandinavia Serbia SGCTG-Scotland SGOG-China

  21. INductionChemoThERapy in Locally Advanced CErvical Cancer-INTERLACEMary McCormack for the NCRI Gynaecological Clinical Studies Group GCIG Prague Oct 2010

  22. INTERLACE A phase III trial of weekly, dose dense, induction chemotherapy followed by chemoradiation versus chemoradiation alone in locally advanced cervical cancer

  23. INTERLACE - Phase 3 trial Randomise CarboplatinAUC2 & Paclitaxel80mg/m2 Weeks 1-6 Standard CRT Standard CRT : 40—50.4Gy in 20-28 fractions plus Intracavitybrachytherapy to give min total EQD2 dose of 74-80Gy to point A/volume. Weekly cisplatin 40mg/m2 x 6 weeks Weeks 7 – 13 Standard CRT Follow-up 3 monthly for 2 years; 6 monthly for 3 years

  24. Proposal- Current Status • Full Proposal for funding submitted August decision expected early November 2010 • Open to recruitment –June/July 2011 • Collaborators- UK ( 22 ) • Eire ( 2 ) • France • India (1) • South Africa (2) Contact: Lindsay James Cancer Research UK and UCL Cancer Trials Centre l.James@ctc.ucl.ac.uk

  25. A phase III trial comparing efficacy and cost-effectiveness between Weekly and Three-Weekly cisplatin Chemotherapy for Chemoradiation in Cervical Cancer An international, multi-center, randomized Phase III GCIG trial led by TGCS, KGOG (TAKO)

  26. Schema Control Arm; Weekly Cisplatin 40mg/m2 6 cycles Randomization Cervical cancer Locally advanced cervical cancer Stage IIB-IVA Study Arm; Tri-weekly Cisplatin 75mg/m2 3 cycles

  27. Principal Investigator: Dr. Sarikapan WilailakFaculty of Medicine Ramathibodi Hospital, Mahidol university, Bangkok, Thailand Principal Investigator: Dr. Sang Young RyuKorea Cancer Center HospitalSeoul, Korea

  28. Cervical cancer in underdeveloped nations

  29. Proposal for GCIG Cervix Cancer Network of Trial Centres in non-GCIG Countries

  30. Clinical Trial Summary • One trial looking at less radical surgery in low risk cervical cancer patients. • Two advanced/recurrent randomized trials. • One trial looking at chemo/RT vs. RT alone after hysterectomy in intermediate risk patients. • Three trials investigating adjuvant chemotherapy in high risk cervical cancer. • +/- Neoadjuvant than chemo/RT. • Post-hysterectomy chemo/RT+/- adjuvant chemo • Chemo/RT +/- adjuvant chemo • One limited resource trial looking at reduced frequency of concurrent cisplatin in chemo RT patients

  31. Goals • Activate developing trials. • Foster collaboration and rapid accrual to open trials • Develop a working group to help advance therapy in underdeveloped countries.

  32. Please attend the site specific trials

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