Influence of Lengthening the Interval Between Radiochemotherapy and Surgery on Complete Pathological Response in Rectal Cancer (GRECCAR6)

July 22, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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))

Study Type

Interventional

Enrollment (Actual)

265

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Saint-Antoine Hospital - AP-HP, Department of general and digestive surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 18 years, no age limit higher
  • Performance status evaluated by the Eastern CooperativeOncology Group (ECOG) score: 0-1,
  • 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 45-51 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 excision,
  • Free and informed consent signed by the patient,
  • Patient affiliated to a social security scheme or beneficiary of such plan(except AME)
  • Patient able, according to the investigator, to comply with the requirements of the study.

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

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 cervix) old less than 10 years
  • 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,
  • Patient did not complete the full protocole of chemotherapy,
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 11 weeks
The cancer surgery is practice 11 weeks after neoadjuvant radio-chemotherapy
Procedure: Surgery after 11 weeks of delay after chemoradiotherapy.
Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 11 weeks of delay after the end of chemoradiotherapy.
Other: 7 weeks
The cancer surgery is practice 7 weeks after neoadjuvant radio-chemotherapy
Procedure: Surgery after 7 weeks of delay after chemoradiotherapy
Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 7 weeks of delay after the end of chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of clinical response to radio-chemotherapy before surgery, comparison between the two groups (7 versus 11 weeks)
Time Frame: 6 month
6 month
Rate of tumor regression, comparison between the two groups (7 versus 11 weeks)
Time Frame: 6 month
6 month
Rates of operative mortality and morbidity at 90 days, comparison between the two groups (7 versus 11 weeks)
Time Frame: 6 month
6 month
Quality of mesorectum resection, comparison between the two groups (7 versus 11 weeks)
Time Frame: 6 month
6 month
Rate of sphincter preservation, comparison between the two groups (7 versus 11 weeks)
Time Frame: 6 month
6 month
Local and distant recurrence rates, comparison between the two groups (7 versus 11 weeks)
Time Frame: 5 years
5 years
Overall survival and disease-free survival rates, comparison between the two groups (7 versus 11 weeks)
Time Frame: 5 years
5 years
Functional results (LARS score)
Time Frame: 24 months and 36 months
LARS questionnaire (Low Anterior Resection Syndrome questionnaire) completed at 24 months and 36 months
24 months and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jérémie Lefèvre, MD, Assistance Publique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2012

Primary Completion (Actual)

October 22, 2015

Study Completion (Actual)

May 6, 2020

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 110125
  • AOM 11304 (Other Identifier: Assistance Publique)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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