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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

Phase 3
18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

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

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 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))

Inclusion Criteria:

- age over 18 years, no age limit higher

- Performance status evaluated by the Eastern CooperativeOncology Group (ECOG) score:

- Patients with cancer of the middle or lower rectum (lesion located within 10 cm from
the dentate line or 12 cm from the anal margin) proved by pathology,

- T3-T4N0, TxN+ on ultrasound-endoscopy and MRI, without secondary localization (M0) on
the thoracoabdominal (or chest radiography and abdominal ultrasound)

- Patient who received a protocol between 45-50 Gy of radiotherapy and chemotherapy
based on 5-fluorouracil for an average duration of 5 weeks for the management of
rectal cancer,

- Curative surgical treatment planned following radiochemotherapy with total mesorectal

- Free and informed consent signed by the patient,

- Patient affiliated to a social security scheme or beneficiary of such plan(except

- Patient able, according to the investigator, to comply with the requirements of the

The cessation of chemotherapy during radiotherapy does not exclude the patient from the

Exclusion Criteria:

- Patient with metastasis,

- T1 or T2N0 tumor classified by echo-endoscopy and MRI,

- rectal tumor with lower pole is more than 12 cm from the anal margin or 10 cm from
the dentate line,

- Patient did not complete the full protocol of radiotherapy,

- History of tumors (other than basal cell carcinoma and / or carcinoma in situ of the

- A patient with impaired or incompetent investigator by not allowing him a good
understanding of the requirements of the study,

- Person under guardianship, persons under guardianship, persons deprived of their
liberty by judicial or administrative body, adult subject to legal protection or
unable to consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 month

Safety Issue:


Principal Investigator

Jérémie Lefèvre, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

P 110125



Start Date:

October 2012

Completion Date:

February 2020

Related Keywords:

  • Rectal Cancer
  • Rectal cancer
  • radiochemotherapy
  • complete pathological response
  • Rectal Neoplasms