A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and
general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients,
radiochemotherapy improves the local control but the metastatic risk remains about 30% with
enhanced postoperative morbidity and poor functional results. The tumor response to
preoperative treatment is the major prognostic factor which revealed the aggressiveness of
the tumor. To this day, there are no biologic predictive markers for tumor response.
The purpose of this trial is to tailor the management according to the early tumoral
response after short and intensive induction trichemotherapy. MRI volumetric tumor response
will be used to distinguish between good responders and bad responders.
"Very good" responders will be randomized to either immediate surgery or radiochemotherapy
followed by surgery (Standard arm: Cap 50). "Good or bad" responders will be randomized
between two arms: intensive radiochemotherapy (Cap 60) or the standard arm (Cap 50).
This tailored management should result in a better oncologic prognosis with a lower rate of
post therapeutic functional disorders.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Ro resection rate
To confirm the feasibility of a tailored management with a 90% R0 resection rate achieved for all arms.
Within 15 days after surgery
Philippe ROUANET, MD, Ph D
CRLC Val d'Aurelle-Paul Lamarque
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)