Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01648894 |
| Other study ID # |
P 110125 |
| Secondary ID |
AOM 11304 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2012 |
| Est. completion date |
May 6, 2020 |
Study information
| Verified date |
July 2022 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
At the end of the neoadjuvant radiochemotherapy, patients are seen by their surgeon to
planify the surgery. During this visit, the study will be explained them and their consent
obtained. They will then be randomized between the two groups 7 weeks vs. 11 weeks. Patients
were reviewed 15 days before surgery and at 1 and 3 months after surgery. Participation in
this study does not change treatment, investigations and consultations usually necessary for
management of rectal cancer. The objective is to improve the pathological complete response
rate of the rectal cancer.
Description:
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 electronic Case Report Form (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 randomization.
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
investigations.
Not specific exam is requested in the study.
M2 or M3
Surgical procedure:
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 Rödel (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))
