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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01648894
First received: July 20, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Procedure: Surgery after 11 weeks of delay after chemoradiotherapy.
Procedure: Surgery after 7 weeks of delay after chemoradiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of clinical response to radio-chemotherapy before surgery, comparison between the two groups (7 versus 11 weeks) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Rate of tumor regression, comparison between the two groups (7 versus 11 weeks) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Rates of operative mortality and morbidity at 90 days, comparison between the two groups (7 versus 11 weeks) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Quality of mesorectum resection, comparison between the two groups (7 versus 11 weeks) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Rate of sphincter preservation, comparison between the two groups (7 versus 11 weeks) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Local and distant recurrence rates, comparison between the two groups (7 versus 11 weeks) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival and disease-free survival rates, comparison between the two groups (7 versus 11 weeks) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: October 2012
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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 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 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))

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 45-50 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 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)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648894

Contacts
Contact: Jérémie Lefèvre, MD + 33 (0) 1 49 28 25 43 jeremie.lefevre@sat.aphp.fr

Locations
France
Saint-Antoine Hospital - AP-HP, Department of general and digestive surgery Recruiting
Paris, France, 75012
Contact: Yann Parc, MD, PhD         
Principal Investigator: Yann Parc, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jérémie Lefèvre, MD Assistance Publique
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648894     History of Changes
Other Study ID Numbers: P 110125, AOM 11304
Study First Received: July 20, 2012
Last Updated: March 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rectal cancer
radiochemotherapy
complete pathological response

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 18, 2014