scholarly journals Harmonising clinical trials within the Gynecologic Cancer InterGroup: consensus and unmet needs from the Fifth Ovarian Cancer Consensus Conference

2017 ◽  
Vol 28 ◽  
pp. viii30-viii35 ◽  
Author(s):  
M.A. Bookman ◽  
A. Okamoto ◽  
G. Stuart ◽  
N. Yanaihara ◽  
D. Aoki ◽  
...  
2011 ◽  
Vol 21 (4) ◽  
pp. 771-775 ◽  
Author(s):  
Michael Friedlander ◽  
Edward Trimble ◽  
Anna Tinker ◽  
David Alberts ◽  
Elisabeth Avall-Lundqvist ◽  
...  

The 4th Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup was held in Vancouver, Canada, in June 2010. Representatives of 23 cooperative research groups studying gynecologic cancers gathered to establish international consensus on issues critical to the conduct of large randomized trials. Group C, 1 of the 3 discussion groups, examined recurrent ovarian cancer, and we report the consensus reached regarding 4 questions. These included the following: (1) What is the role of cytoreductive surgery for recurrent ovarian cancer? (2) How do we define distinct patient populations in need of specific therapeutic approaches? (3) Should end points for trials with recurrent disease vary from those of first-line trials? (4) Is CA-125 progression alone sufficient for entry/eligibility into clinical trials?


2011 ◽  
Vol 21 (4) ◽  
pp. 746-749 ◽  
Author(s):  
Monica Bacon ◽  
Henry Kitchener ◽  
Gavin C.E. Stuart ◽  
Jan B. Vermorken

The Gynecologic Cancer InterGroup (GCIG) has developed from a small network of ovarian cancer researchers to a large international forum addressing multiple issues related to research in gynecologic cancers. Member groups of the GCIG have collaboratively conducted pivotal clinical trials in cancers of the ovary, endometrium, and cervix. The participation of operational and statistical personnel from the GCIG member groups has facilitated a collegial approach to international differences and restrictions.One of the powerful initiatives of the GCIG is the facilitation of the Ovarian Cancer Consensus Conference every few years. The 4th Ovarian Cancer Consensus Conference was held in Vancouver, Canada, in June 2010, and the resulting publications (herein) provide an invaluable resource to researchers in the field of gynecologic oncology.


2011 ◽  
Vol 21 (4) ◽  
pp. 750-755 ◽  
Author(s):  
Gavin C.E. Stuart ◽  
Henry Kitchener ◽  
Monica Bacon ◽  
Andreas duBois ◽  
Michael Friedlander ◽  
...  

2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer. This report provides the outcomes from the Fourth Ovarian Cancer Consensus Conference.


Cells ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. 903
Author(s):  
Daniela Califano ◽  
Daniela Russo ◽  
Giosuè Scognamiglio ◽  
Nunzia Simona Losito ◽  
Anna Spina ◽  
...  

Ovarian cancer is the most lethal gynecological cancer, and despite years of research, with the exception of a BRCA mutation driving the use of PARP inhibitors, no new prognostic/predictive biomarkers are clinically available. Improvement in biomarker selection and validation may derive from the systematic inclusion of translational analyses into the design of clinical trials. In the era of personalized medicine, the prospective centralized collection of high-quality biological material, expert pathological revision, and association to well-controlled clinical data are important or even essential added values to clinical trials. Here, we present the academic experience of the MITO (Multicenter Italian Trial in Ovarian Cancer) group, including gynecologists, pathologists, oncologists, biostatisticians, and translational researchers, whose effort is dedicated to the care and basic/translational research of gynecologic cancer. In our ten years of experience, we have been able to collect and process, for translational analyses, formalin-fixed, paraffin-embedded blocks from more than one thousand ovarian cancer patients. Standard operating procedures for collection, shipping, and processing were developed and made available to MITO researchers through the coordinating center’s web-based platform. Clinical data were collected through dedicated electronic case report forms hosted in a web-based electronic platform and stored in a central database at the trial’s coordinating center, which performed all the analyses related to the proposed translational researches. During this time, we improved our strategies of block management from retrospective to prospective collection, up to the design of a prospective collection with a quality check for sample eligibility before patients’ accrual. The final aim of our work is to share our experience by suggesting a guideline for the process of centralized collection, revision processing, and storing of formalin-fixed, paraffin-embedded blocks for translational purposes.


2011 ◽  
Vol 21 (4) ◽  
pp. 763-770 ◽  
Author(s):  
Jonathan A. Ledermann ◽  
Christian Marth ◽  
Mark S. Carey ◽  
Michael Birrer ◽  
David D.L. Bowtell ◽  
...  

There is now a greater understanding of the molecular pathways in ovarian cancer, and using this knowledge, a large number of new therapeutic agents can be tested. The success of these drugs will depend on selecting drugs that target known key dysfunctional molecular pathways. To make best use of these compounds, prognostic and predictive biomarkers need to be identified. Novel methods of assessment such as functional imaging need to be developed as additional biological end points to evaluate these therapies. Promising antitumor activity has been observed with some drugs, and careful consideration is needed to determine in what circumstances new agents, such as antiangiogenic compounds, could be considered as a standard therapy. These areas were discussed at the 4th Ovarian Cancer Consensus Conference.


2017 ◽  
Vol 28 (4) ◽  
pp. 727-732 ◽  
Author(s):  
M.K. Wilson ◽  
E. Pujade-Lauraine ◽  
D. Aoki ◽  
M.R. Mirza ◽  
D. Lorusso ◽  
...  

2010 ◽  
Vol 20 (6) ◽  
pp. 971-978 ◽  
Author(s):  
Evis Sala ◽  
Nandita DeSouza ◽  
Susanna I. Lee ◽  
Mostafa Atri ◽  
Hedvig Hricak

The Gynaecological Cancer InterGroup conducts collaborative trials in gynecologic cancer and also aims to develop standards that can be used to strengthen all aspects of study methodology. There is an urgent need to develop more refined imaging end points that can be used as early treatment response biomarkers in ovarian cancer. Therefore, the Gynaecological Cancer InterGroup commissioned an expert position paper on the role of functional imaging as an end point in clinical trials in ovarian cancer. In this position paper, we state the limitation of current anatomical imaging methods used in clinical trials, highlight the potential of functional imaging, and provide key recommendations on the use of functional imaging as an end point in ovarian cancer clinical trials.


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