PRODIGE 13 is a cooperative prospective multicentre controlled phase III trial evaluating by double randomisation the impact of intensive radiological monitoring versus a standard one and CEA monitoring versus no monitoring in Stage II or III colorectal cancer. This abstract describes patient's baseline characteristics.
Recommendations for colorectal cancer, according to various scientific societies have been based on heterogeneous clinical trials, and indeed mainly on expert opinions. Differences still exist particularly concerning the imaging techniques used. The CEA dosage is also poorly evaluated. Despite their limits, recent trials suggest that survival is increased thanks to clinical monitoring combined with hepatic and pulmonary imaging and possibly CEA assay. PRODIGE 13 is a large randomised trial of monitoring strategy and will evaluate the strategies to eliminate existing doubts in 1997 patients (pts) recruited in 96 centers in France and Belgium. The primary endpoint is 5-year overall survival (OS). The design with 4 arms is already described in a publication (Lepage C et al., Dig Liver Dis, 2015)
On the 1997 pts included between 09/2009 and 04/2015, 59% were men, 76% were less than 75 years old and OMS was 0 for more than 66% of the pts. Around 50 % were Stage II (treated or not) and 12% were previously included in a adjuvant trial (mainly IDEA). Sixteen % were rectum cancer, 44% were left colon cancer. More than 90% of the cancers were well-differentiated. For the rectum primary tumor, 83% of the pts received at least one treatment (chemotherapy or radiotherapy) and it was mainly pre-operative treatment (70%). For the colon primary tumor, 60.5% of the pts received at least one treatment, mainly post-operative treatment (99%). According to EuroQol questionnaire, median Visual Analog Scale was 75 mm [range: 2-100] meaning that most of the pts felt in a good health.
The study will show the effect of intensive follow-up versus standard follow-up in Stage II or Stage III colorectal cancer patients. The survival results of the study will be reported in 2021 (6 years after last patient randomization).
Clinical trial identification
Legal entity responsible for the study
C. Lepage: has a conflict of interest with: Ipsen. J-M. Phelip: received grant/reseach support from: Amgen, Merck, Roche Glycart, is a consultant/advisor for industry from: Sanofi, Bayer, Lilly, Ipsen, Novartis, Merck, Amgen, Celgene, Roche Glycart. O. Bouché: received grant/reseach support from: Pierre Fabre, is a consultant/advisor for industry from: Roche, Merck Serono, Teva, is speaker bureau from : Novartis, Lilly, Amgen,Hospira, has a conflict of interest with: Amgen. All other authors have declared no conflicts of interest.