Randomized Control Trial Comparing the Impact of a Lengthening of the Interval Between the Radiochemotherapy and Surgery (7 Weeks vs. 11 Weeks) on Complete Pathological Response in Rectal Cancer
D0: Visit of inclusion and randomization After the end of chemoradiotherapy, the patient is
seen in consultation by her / him a surgeon who propose him to participate in the study. At
the end of the visit if the patient agrees to participate in it, the investigator at each
center will conduct the collection of written consent to the inclusion of the patient.
Inclusion will be recorded in the e-CRF by the investigator at each center. Randomization (7
or 11 weeks of delay) is performed by the surgeon via the software module Cleanweb
M1- 1.5 or M2.5 depending of the group randomisation A consultation with the surgeon is held
within 15 days (+/- 5 days) of intervention to check the clinical response (tumor regression
in rectal tumor distance from the dentate line) and planify surgery. During this visit, the
surgeon noted in the e-CRF, clinical findings of the lesion and the results of further
Not specific exam is requested in the study.
M2 or M3
The anesthesia consultation is planned before the surgery according to the habits of
service. Participation in the study does not alter the anesthetic procedures.The patient is
admitted the day before surgery in the surgical ward.
During surgery, the operating data are provided on the e-CRF (digital rectal examination
under general anesthesia, type of surgery (anterior resection or abdominal-perineal
resection), operative time, intraoperative bleeding, macroscopic appearance of the
mesorectum, distance from the distal limit of resection). The postoperative complications
are noted by the surgeon in the e-CRF during hospitalization (about 10-15 days), and data
reporting pathological (Annex 2).
Pathological examination of the specimen of proctectomy is performed according to
recommendations for clinical practice using the standard form (Annex 2). The tumor response
is evaluated by inclusion of all residual tumor and the response to chemoradiotherapy is
graded with the scale of Rodel (Annex 5). A double reading of slides will be made for each
patient by two independent pathologists blinded to the randomization group of the patient.
M2 - M5 or M3 - M6 :
Postoperative follow-up :
Following the intervention, no specific consultation is necessary. At follow-up
consultations (1 month, 3 months) the surgeon evaluate the postoperative course, planify the
stoma closure, noted the potential adverse events and results of morphological examinations
(computed tomography, ultrasound, endoscopy) and biological (markers) eventually prescribed.
M6 - M60 :
Cancer surveillance :
Regular follow-up every 3-4 months fo the first two years and every 6 months for the last
remaining 3 years (clinical examination, CT-scan and biological marker (CEA))
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of pathological complete response after pathological examination of surgical specimen defined by the absence of persistent tumor cell invasion and lymph node (ypT0N0) in group 7 weeks versus 11 weeks in the group
Jérémie Lefèvre, MD
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)