GYNECOLOGIC CANCER INTERGROUP (GCIG)
GENERAL ASSEMBLY
FRIDAY, JUNE 4, 2010,
8:00 A.M. , CHICAGO, USA
MINUTES
Present:
Members:
ACRIN:
AGO-Au:
AGO-de:
ANZGOG:
COGI:
DGOG:
EORTC-GCG:
GEICO:
GICOM:
GINECO:
GOG:
ICORG:
JGOG:
KGOG:
MaNGO:
MITO:
MRC/NCRI:
NCIC CTG:
NSGO:
RTOG:
SGCTG:
SWOG:
Ex-Officio:
S.Lee
C.Marth, A.Zeimet
A. du Bois, P.Harter,S.Polleis, A.Reuss, J.Sehouli, J.Pfisterer
A.Brand, D.Rischin, M.Friedlander, J.Martyn, L.Mileshkin, V.Gebski
J.Berek
C.Creutzberg, N.Ottevanger, E.Witteveen
A.Casado, I.Vergote
A.Cervantes, A.Oaknin, A.Poveda, F.Nepote, A.Gonzalez, J.delCampo
D.Gallardo, JA.Guerrero
B.Weber, F.Joly, J.Kurz, N.leFur, B.Votan
M.Birrer, M.Brady, B.Stonebraker, T.Thigpen, B.Monk, D.Miller
D.O’Donnell
E.Aotani, K.Fujiwara, A.Okamoto, S.Sagae, N.Susumu, T.Hamano
JWKim, S.Ryu, YM.Kim
C.Sessa, N.Colombo, R.Fossati
D.Lorusso, F.Bellati
M.McCormack, H.Kitchener, J.Ledermann, C.Gourley, L.James, A.Clamp
G.Stuart, A.Oza, P.Craighead, D.Provencher, D.Tu, M.Bacon
G.Andersen, G.Kristensen, M.Mirza, U.Puistola, E.Avall-Lundqvist
D.Gaffney, B.Miller, W.Small, K.Winter, A.Jhingran, A.Viswanathan
D.Millan, J.Paul, N.Siddiqui, S.Kaye
M.Bookman, M.Markman, G.Anderson
M.Powers, J.Vermorken
Nat’l Authority:
NCI US:
T.Trimble, B.Greer, W.Hoskins, G.Thomas, S.Dowdy, D.Gershensen
Observers:
TRSGO:
Poland:
China:
Romania:
Georgia:
Czech.Rep:
Thailand:
Brazil:
Russia:
Lithuania:
Bosnia/Herz:
Greece:
G.Tulaney
A.Danska-Bidzinska
R.Zang
O.Coza
T.Charkviani, I.Dvalishvili
R.Lukas, H.Robova
E.Sirachainan
regrets
regrets
regrets
regrets
regrets
Pharma/Biotech Partners:
TAIHO:
Y.Tachibana
AstraZeneca:
J.Carmichael
EliLilly:
T.Bauknecht
BoehringerIngelheim:
M.Merger
Pharmamar:
M.Julian, C.Lebedinsky
Amgen:
D.Warner
GSK:
(?? R.Crescenzo??)
Guests:
J.Tidy, D.Chi, L.Hartmann, Fasching
Continental Breakfast
Welcome& Introductions
Kitchener
Secretariat Report
 Operations Manager: (full report to Executive)
Bacon
Minutes Oct.11, 2009
Motion – D.Miller; seconded – K.Winter; all in favour.
Attendance report – 125 registrations;
-- all member groups represented;
-- observers from TRSGO, Poland, China, Romania, Georgia, CzechRep. & Thailand;
-- TAIHO, EliLilly & AstraZeneca joined by new Industry Partners: B.I., Pharmamar,
Amgen and GSK;
Finances - Account balance: $170,000.00 Cdn.
-- 2010-2011 Dues invoices forthcoming.
Attendance Sheet circulating – please sign in.
 Webmaster:(full report to Executive)
Powers
Attendance certificates available.
Update presented re: GCIG website (on the IGCS homepage); password
protected pages and listserves for committees/working groups in progress.
Membership Committee
----
(full report to Executive – see E.B. minutes)
Avall/Pfisterer/Stuart
Membership document (including criteria) updated;
Member groups will be re-evaluated every 2 years;
GICOM, ICORG and COGI all granted probational membership status;
TRSGO, SGOG and others continue as Observer status with mentoring;
Reminder that representation at Harmonization Committee is required for all member groups.
Executive Board Report
(See E.B. minutes for full report)
Kitchener
ref: Financial Report: might be consideration to assist Harmonization reps in GCIG attendance
expenses if requested;
Updated Governance and Statutes documents posted on the website.
Principles of Independence [prior: Academic vs Industry Trials] -- approved document will be posted
Publications/manuscripts/presentations:
Uncommon histologies paper in press (IJGC);
2009 GCIG//NCI US Ovarian Ca CTPM – manuscript in progress (Trimble);
2009 Cervix Ca SOtS – manuscript in progress (Kitchener);
Classifications – unpublished paper provided to 4th OCCC delegates (Thigpen);
RT presentation (Oct.2009) – manuscript submitted (Sala);
Dermoid paper in press (Friedlander);
Brachytherapy/Cervix in press (Gaffney).
-Incorporation --- establishment of GCIG as a non-profit legal entity being investigated by Exec.
[independent versus umbrella’d]
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Member Groups – Updates/News
ACRIN
Lee
AGO-Au
Marth
AGO-De
Pfisterer
ANZGOG
Friedlander
COGI
Berek
DCGOG
Creutzberg
EORTC-GCG
Casado
GEICO
Poveda
GICOM
Gallardo
GINECO
Pujade-Lauraine
GOG
Thigpen
ICORG
O’Donnell
JGOG
Fujiwara
KGOG
Kim
MaNGO
Fossatti
MITO
Lorusso
MRC/NCRI
Ledermann
NCI US
Trimble
NCIC CTG
Oza
NSGO
Kristensen
RTOG
Gaffney
SGCTG
Siddiqui
SWOG
Markman
Most groups had no crucial news to impart.
A common theme to be noted: increasing beaurocratic obstacles in conducting clinical trials and collaboration.
ENGOT Status:
Vergote
- network of European groups facilitating collaboration within the regulatory framework of the EU
Directive (including non-GCIG independent eastern European researchers).
- continuing to address EU Directive inconsistencies.
FDA & EMEA joint GCP Initiative:
continuing to address barriers to collaboration in cancer research trials
attempting harmonized and parallel licensing trials in Europe & USA
Trimble
NCI US Initiative (International Collaboration):
US & UK moving forward with Rare Cancers
Trimble
Disease Site Reports:
Ovarian Cancer
 Standing Committee report (see attached)
 Symptom Benefit working group (see attached)
 4th OCCC Update – (June 25-27,2010)
 Response/Progression (updated CA 125paper in progress)
Endometrial Cancer (+GTD)
 Standing Committee report (see attached)
Marth /Harter
Friedlander/B.Miller
Stuart
Rustin
D.Miller/D.Lorusso
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Cervix Cancer (+ vulvar, vagina)
 Standing Committee report (see attached)
Small/Sagae
 GCIG Cervix Cancer Research Network
Kitchener

– document drafted (criteria for participants) and reviewed by Exec. and Cervix Ca Committee co-chairs;

-- aim is to facilitate non-GCIG qualified groups/countries to join GCIG cervix cancer clinical trials;

-- document currently usable for mentoring;

-- minor revisions underway; audits/inspections section needs clarification.
Harmonization Standing Committee Report
- Operations (see attached)
- Statisticians (see attached)
Working Groups Reports;
Rare Tumours (incl. carcinosarc. and borderline) (see attached)
Translational Research: (see attached)
Martyn
Brady
Gershensen/Ray-Coquard
Birrer/McNeish
FIGO Liaison Report: nothing heard from FIGO
Beverage Break
Educational Session:
Pharmacogenetics in epithelial ovarian cancer
Fasching/Hartmann
Adjourn
Next Meetings
-
Thursday-Friday, Oct. 21-22,2010, Prague (IGCS Sat23rd – Tu.26th)
June 2011, Chicago (ASCO June 3 – 7, 2011)
Autumn 2011
May 31 & June 1, 2012, Chicago (ASCO June 1 – 5, 2012))
Autumn 2012
Respectfully Submitted
Monica Bacon
GCIG Operations Manager
12:30pm: Executive Board meeting
2:00pm – 8:00pm GCIG Trial specific meetings
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