Download NCCTG IDEA Newsletter (WEB-only) - MC4094-01

IDEA Update
International Duration Evaluation of Adjuvant Chemotherapy (IDEA) Colon Cancer Prospective Pooled Analysis
A newsletter for IDEA investigators
May 2015
Collaboration Update
IDEA colleagues, as we enter 2015, the IDEA group
continues to make substantial progress. Two trials
remain open, the CALGB/SWOG trial and the HORG
trial, and both should complete accrual by the end
of 2015.
In January 2015 the number of events were updated.
Thanks to all investigators and statisticians for
providing this information. The good news is
that overall the number of events is tracking very
closely to projections. There is slight heterogeneity
by study, but since formal data sweeps have not
been conducted, uniformly among trials is likely a
differential delay in reporting between studies.
Thanks to the efforts of the Steering Committee,
and particularly Lindsay Renfro, Ph.D., at the Mayo
Clinic research base, a paper was recently published
providing details on the modeling process for
estimating the number of events over time, and thus
the timing of the final IDEA analysis. Based on the
projections, and the January event count, (which will
be updated every 6 months) we remain on target for
a final IDEA analysis in the second half of 2016.
While enrollment to IDEA studies is winding down,
continued vigilant follow-up and data collection for
all trials remains critical. We know that the colon
cancer research and patient communities worldwide are eagerly awaiting our results, which we
wish to provide as soon as possible.
Efforts will be initiated in late 2015 or early 2016 to
facilitate rapid data collection and analysis once the
number of events required for analysis has been
observed.
Thus, we continue to have good progress on
the IDEA project. Thank you for all of your
contributions to IDEA.
IDEA Steering Committee: Timothy Iveson, M.D., principal investigator (P.I.), Short Course Oncology Treatment
(SCOT) trial; Jim Paul, M.S., SCOT trial; Roberto Labianca, M.D., co-P.I., Three or Six Colon Adjuvant (TOSCA) trial;
Alberto Sobrero, M.D., co-P.I., TOSCA trial; Jeffrey Meyerhardt, M.D., M.P.H., Cancer and Leukemia Group B (CALGB)
chair, C80702 trial; Anthony Shields, M.D., Ph.D., P.I., Southwest Oncology Group (SWOG), C80702 trial; Thierry
André, M.D., co-P.I., PRODIGE-Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) trial; Julien Taieb,
M.D., co-P.I., PRODIGE-GERCOR trial; Atsushi Ohtsu, M.D., co-P. I., ACHIEVE trial; Takayuki Yoshino, M.D., co-P.I.,
ACHIEVE trial; Ioannis Souglakos, M.D., P.I., Hellenic Oncology Research Group (HORG); Axel Grothey, M.D.,
North Central Cancer Treatment Group (NCCTG) Secretariat; Daniel Sargent, Ph.D., NCCTG Secretariat.
IDEA Coordination Committee: Donna Niedzwiecki, Ph.D., (CALGB); Irene Floriani, Ph.D., (TOSCA);
Jim Paul, M.S., (SCOT); Frank Bonnetain, Ph.D., (PRODIGE-GERCOR); and Daniel Sargent, Ph.D., (Secretariat).
Accrual Update
Cancer and Leukemia Group B (CALGB)/
Southwest Oncology Group (SWOG) trial C80702
Activation date: July 2010
Current status: Open
Planned accrual: 2,500 patients
Sites open: 588 sites are listed in ClinicalTrials.
gov – endorsed by all adult oncology treatment
cooperative groups in the US and Canada
Current accrual: 2,120 patients, current accrual rate
is approximately 50 participants per month.
HORG trial
Activation date: October 2010
Current status: Open
Planned accrual: 1,000 patients
Sites open: 15 sites have been activated (13 have at
least one patient enrolled)
Current accrual: 656 patients with stage III colon
cancer. Accrual rate has been slow for the past
3 months due to problems with availability of
oxaliplatin.
Timeline for IDEA Colon Cancer Prospective Pooled Analysis
2009
2007
• June 2007: Three
or Six Colon
Adjuvant (TOSCA)
trial opens
• May 2009:
PRODIGE-Groupe
Coopérateur
Multidisciplinaire en
Oncologie (GERCOR)
trial opens
2013
2011
• November 2013:
SCOT trial closes,
accruing 4,018
stage III colon
cancer patients
2015
2008
2010
2012
2014
2016
• March 2008: Short
Course Oncology
Treatment (SCOT)
trial opens
• July 2010: Cancer
and Leukemia Group
B (CALGB)/Southwest
Oncology Group
(SWOG) trial C80702
opens
• October 2010: HORG
trial opens
• August 2012:
Japanese
Foundation for
Multidisciplinary
Treatment of Cancer
JFMC 47-1202-C3
(ACHIEVE) trial
opens
• December 2012:
TOSCA trial closes,
accruing 2,436
stage III colon
cancer patients
• April 2014: PRODIGEGERCOR trial closes;
accruing 2,020 stage
III colon cancer
patients
• May 2014: interim
analysis completed
• June 2014: ACHIEVE
trial closes; accruing
1,313 stage III colon
cancer patients
•September
2016: Projected
final analysis
IDEA Overview
The purpose of International Duration Evaluation
of Adjuvant Chemotherapy (IDEA) is to facilitate
the collaboration among multiple individual trials
conducted around the world for a single, pooled
analysis of the primary aim: To test whether 3
months of oxaliplatin-based adjuvant therapy is
non-inferior for disease-free survival (DFS) to 6
months of the identical therapy in patients with
stage III colon cancer.
The IDEA Steering Committee is comprised of
2 members from each group coordinating
an individual trial, plus 2 members from a
Secretariat, North Central Cancer Treatment
Group (NCCTG), who are responsible for
coordinating the data pooling and the joint
analysis. (See list on page 1.)
Individual trials included in IDEA may address
additional trial-specific hypotheses in a
factorial design; the analyses of these additional
hypotheses will be trial-specific and not involve
IDEA.
The IDEA pooled analysis will consist only of
stage III colon cancer patients enrolled in these
trials. Only patients randomized to 3 or 6 months
of a FOLFOX regimen (FOLFOX4 or mFOLFOX6)
or XELOX will be included in the pooled analysis.
The trials in IDEA share accrual information on
an ongoing basis (at least every 6 months). The
final pooled analysis will be conducted jointly
by the IDEA Steering Committee, with the
Secretariat and main data analysis site at Mayo
Clinic/NCCTG.
Members of IDEA have agreed to pool the
data from their individual trials to allow a
definitive analysis consisting of at least 10,500
patients, using DFS as the primary endpoint.
Non-inferiority will be declared if the 2-sided
95%confidence interval for the hazard ratio
comparing 3 to 6 months of therapy lies entirely
below 1.12.
A sample size of 10,500 patients provides 90%
power, based on an expected accrual duration
of 3.5 years, 3 years minimum follow-up, and an
expected 3-year DFS rate in the control group of
72% to declare non-inferiority if the true hazard
ratio is 1.0.
Contact
information
For further information on IDEA, contact the IDEA Secretariat at:
Mayo Clinic Cancer Center
200 First Street S.W.
Rochester, Minnesota 55905
E-mail: [email protected]
MC4094-01rev0515