gcig group experiences: ago-austria
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Gynecologic Cancer InterGroup
GCIG Group Experiences:
AGO-Austria
Christian Marth
GCIG Education Symposium, November 2017, Vienna
Key Points: We Need To Work Together…
• …since international collaboration in cancer
treatment trials has become increasingly important
from a scientific perspective.
• … to overcome regulatory and logistical barriers to
greater international collaboration.
• … to strengthen financial, regulatory, and logistic
support from government, academia, and local
institutions for academic clinical trials.
• … to induce and perform academic clinical trials in
complement to those run by pharmaceutical
companies.
Why Is International Collaboration in Cancer Clinical Trials Important?
1. More effective treatment for cancer
2. We need larger sample sizes in our trials to identify further improvements or to determine similar efficacy of a less-toxic regimen.
3. Molecular biology to help determine eligibility for trials. We must cast a wider net to find patients with the appropriate molecular classification.
4. To study rare diseases and less common cancers, we need global collaboration.
5. To evaluate the large number of promising new treatments, we need to complete definitive clinical trials rapidly.
6. Conduct of large trials across many countries permits us both to determine whether our clinical trial results are generalizable and to facilitate the introduction of new effective therapy into standard practice globally.
Du Bois A, et al. Int J Gynecol Cancer. 2005;15(2):183-191.
Clinical Trials: Pattern of Care and Impact of Participation in Clinical Studies on the Outcome in Ovarian Cancer
2002 - First AGO Trial
AGO 04 Caelyx Gemzar(Edgar Petru)
January 2002 – June 2004
Random. phase II trial
Caelyx + Gemzar vs. Caelyx mono in platinum-refractory and platinum-resistant epithelial
ovarian, fallopian tube and peritoneal cancer
AGO TrialsAGO 01 Xeloda (n.d.)
AGO 02 NeoRecormon
Protokoll1 (n.d.)
AGO 03 NeoRecormon
AGO 04 Caelyx Gemzar
AGO 05 Campto
AGO 06 Topotecan
AGO 07 Mamma3
AGO 08 Calypso
AGO 09 Tarceva
AGO 10 MyocetGemzar
Random
AGO 11 Ovar Protektion (n.d.)
AGO 12 FAME-Endo
AGO 13 Desktop II
AGO 14 Cervix1
AGO 15 Myocet
AGO 16 IP-Therapie
AGO 17 Hector
AGO 18 Braun (n.d.)
AGO 19 CAMYLA (n.d.)
AGO 20 Vectibix
AGO 21 VEG Pazopanib /
AGO Ovar 16
AGO 22 PALIDO
AGO 23 REACT (n.d.)
AGO 24 BIBF / AGO Ovar 12
AGO 25 LION
AGO 26 Desktop 3
AGO 27 HPV (n.d.)
AGO 28 Trinova 2
AGO 30 Trinova 3
AGO 32 EN-ov8 Catumaxomab
(n.d.)
AGO 33 PenelopeAGO 35 LAB-SLN011AGO 36 SHAPEAGO 37 ITIC2AGO 38 ThromboseAGO 39 Ovar 2.21AGO 40 NOVA
AGO 41 MILOAGO 42 PITVINAGO 43 GANNET53AGO 44 Expression IVAGO 45 LUSTICAGO 46 INOVATYON
AGO 47 PAOLA-1AGO 48 Corail
AGO R01 Breastcancer duringpregnancy
Medicinal product Surgical
Questionnaire Other
Registry /retrospective n.d.=not done
Frauenheilkunde Innsbruck
Study center of the Austrian AGO
32 Active collaborating centers
1 Med Uni Innsbruck
2 Med Uni Wien
3 Med Uni Graz
4 BHS Linz
5 BB Graz
6 BHS Ried i.I.
12 KH Oberpullendorf
13 Univ . Klinikum Salzburg
14 KH Hallein
15 BKH Kufstein
16 LK Neunkirchen
22 KA Rudolfstiftung
23 LK St. Pölten
24 LK Korneuburg
25 BKH Lienz
26 AKH Linz
27 BKH Hall
28 LK Mistelbach
Study centers17 Kaiser Franz Josefspital Wien
18 LK Wiener Neustadt
19 Hanuschkrankenhaus Wien
20 KH Elisabethinen Linz
21 LK Krems
7 Klinikum Wels-
Griesskirchen
8 Wilhelminenspital
Wien
9 KH Hietzing
10 LKH Leoben
11 LKH Klagenfurt
Most Austrian Sites per Trial
AGO 09Tarceva
AGO 12FAME-Endo
AGO 38Thrombose
19 17 16
Questionnaire
Registry
Medicinal product
Enrollment in AGO-Trials
0 100 200 300 400 500 600 700
MUW
MUI
MUG
SALK
LKH Klagenfurt
Ordensklinikum BHS Linz
BB Graz
KH Hietzing
KH Leoben
WSP Wien
AKH Linz/LFKK/Kepler
Klinikum Wels-Grieskirchen
KH Wr. Neustadt
BHS Ried i. I.
KH Kufstein
BKH Lienz
BB Wien
KA Rudolfstiftung
LKH St. Pölten
KH Neunkirchen
KH Oberpullendorf
LK Korneuburg
Privatklinik Villach
Kaiser-Franz-Josef Wien
LK Krems
LK Mistelbach
KH Hallein
Elisabethinen Linz
KH Oberwart
Zwettl
Hanuschkrankenhaus
BKH Hall
Number of patients
48%
50% of patients from 10% of the sites
International Collaboration
• GCIG (28 trial groups, worldwide)
• ENGOT (19 trial groups from 15 Europ. countries)
International trials, exchange of knowledge
https://www.i-med.ac.at/mypoint/news/677590.html
Christian Marth
– ENGOT ChairRegina Berger
– ENGOT Admin Chair
AGO Austria as Leading Group
AGO 28 Trinova 2 (ENGOT-ov6) phase III, randomized, double-blind trial of PLD +
AMG386/placebo in recurrent partially platinum-sensitive or
resistant epithelial ovarian cancer
• Coordination of large international trial with 6 trial
groups
7th Framework EU Grant
AGO 43 GANNET53two-part, multicentre, international phase I and II trial assessing the safety+ efficacy of Hsp90 inhibitor ganetespib in combination with paclitaxelweekly in high-grade serous / endometrioid or undifferentiated platinum-resistant epithelial ovarian cancer
• EU project (7th Framework Programme): 4 European
countries, €6 Mio. grant
• Sponsor & trial management: Medical University of Innsbruck
Currently 2597 Patients in AGO Trials
60
87
93
119
209
250
1028
AGO 08 Calypso
AGO 37 ITIC2
AGO 09 Tarceva
AGO 03 NeoRecormon
AGO 38 Thrombose
AGO 44 Expression IV
AGO 12 FAME-Endo
Questionnaire & registry
Medicinal product
Highest recruiting trials:
Publications
• In total 31 publications of AGO trials
• Most publications: AGO 08 CalypsoA multi-national, randomized, phase III, GCIG Intergroup study comparing
pegylated liposomal doxorubicin (CAELYX®) and carboplatin vs. paclitaxel
and carboplatin in patients with epithelial ovarian cancer in late relapse (> 6
months)
14 publicationse.g. Journal of Clinical Oncology, British Journal of Cancer, Gynecologic Oncology,
Journal of the National Cancer Institute, Annals of Oncology, European Journal of
Cancer
Future Impact of Ongoing
Surgical AGO Trials
• Efficiency of systematic pelvic and para-aortic lymph-adenectomy in patients with advanced ovarian cancerand intra-abdominal complete debulking (AGO 25 LION)
• Improved OS through tumour debulking surgery in addition to chemotherapy after recurrence ofplatinum-sensitive ovarian cancer (AGO 26 Desktop III)
• Non-inferiority of simple hysterectomy and pelvic nodedissection to treatment with radical hysterectomy andpelvic node dissection in terms of pelvic relapse-freesurvival in cervical cancer stage Ia2 (AGO 36 SHAPE)
Current situation
2014: First time that a total of 13 trials were
open for accrual simultaneously, enabling patients to
receive innovative, state of the art treatment
Today: 12 trialsare open for accrual
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