Effect of 5 years of imaging and CEA follow-up to detect recurrence of colorectal cancer - PRODIGE 13 a FFCD and Unicancer phase III trial: baseline characteristics

Date

08 Oct 2016

Session

Poster Display

Presenters

Côme Lepage

Citation

Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370

Authors

C. Lepage1, J. Phelip2, L. Cany3, E. Maillard4, A. Lievre5, T. Chatellier6, R. Faroux7, J. Duchmann8, M. Ben Abdelghani9, G. Breysacher10, P. Geoffroy11, D. Pere-Verge12, A. Pelaquier13, D. Pillon14, J. Ezenfis15, Y. Rinaldi16, A. Darut-Jouve17, M. Duluc18, A. Adenis19, O. Bouché20

Author affiliations

  • 1 Service Hge, CHU Le Bocage, INSERM U866, 21079 - Dijon/FR
  • 2 Service Hge, CHU Nord, St. Etienne/FR
  • 3 Service Radiothérapie Et Oncologie, Polyclinique Francheville, Périgueux/FR
  • 4 Faculté De Médecine, FFCD, 21079 - Dijon/FR
  • 5 Service Maladies De L'appareil Digestif, CHU de Pontchaillou, Rennes/FR
  • 6 Service D Oncologie, Clinique Mutualiste de l'Estuaire, St. Nazaire/FR
  • 7 Service D'hge, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche sur Yon/FR
  • 8 Service D'hge, Centre Hospitalier de Compiègne, Compiegne/FR
  • 9 Service D'oncologie, Centre Paul Strauss Centre de Lutte contre le Cancer, Strasbourg/FR
  • 10 Service De Médecine A, Hopitaux Civils de Colmar, Colmar/FR
  • 11 -, Clinique Saint Vincent, Epernay/FR
  • 12 Service D'hge, CH Saint-Joseph Saint-Luc, Lyon/FR
  • 13 Service Hge, CH Montelimar, Montelimar/FR
  • 14 Service D'hge, CH Fleyriat, Bourg en Bresse/FR
  • 15 Unité De Chimiothérapie, CH de Longjumeau, Longjumeau/FR
  • 16 Service D'hge, Hôpital européen, Marseille/FR
  • 17 -, Centre de Radiothérapie du Parc, Dijon/FR
  • 18 Service D'hge Et D'oncologie, CHU La Timone, Marseille/FR
  • 19 Service Cancérologie Digestive, Centre Oscar Lambret, Lille/FR
  • 20 Médecine Ambulatoire-cancérologie, CHU de Reims - Hôpital Robert Debré, Reims/FR
More

Resources

Background

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.

Methods

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)

Results

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.

Conclusions

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

NCT00995202

Legal entity responsible for the study

FFCD

Funding

FFCD

Disclosure

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.

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings