NCT01648894

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 25, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2015

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2020

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

July 20, 2012

Last Update Submit

July 22, 2022

Conditions

Rectal Cancer

Keywords

Rectal cancerradiochemotherapycomplete pathological response

Outcome Measures

Primary Outcomes (1)

  • 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

    6 month

Secondary Outcomes (8)

  • Rates of clinical response to radio-chemotherapy before surgery, comparison between the two groups (7 versus 11 weeks)

    6 month

  • Rate of tumor regression, comparison between the two groups (7 versus 11 weeks)

    6 month

  • Rates of operative mortality and morbidity at 90 days, comparison between the two groups (7 versus 11 weeks)

    6 month

  • Quality of mesorectum resection, comparison between the two groups (7 versus 11 weeks)

    6 month

  • Rate of sphincter preservation, comparison between the two groups (7 versus 11 weeks)

    6 month

  • +3 more secondary outcomes

Study Arms (2)

11 weeks

EXPERIMENTAL

The cancer surgery is practice 11 weeks after neoadjuvant radio-chemotherapy

Procedure: Surgery after 11 weeks of delay after chemoradiotherapy.

7 weeks

OTHER

The cancer surgery is practice 7 weeks after neoadjuvant radio-chemotherapy

Procedure: Surgery after 7 weeks of delay after chemoradiotherapy

Interventions

Surgery after 11 weeks of delay after chemoradiotherapy.PROCEDURE

Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 11 weeks of delay after the end of chemoradiotherapy.

11 weeks
Surgery after 7 weeks of delay after chemoradiotherapyPROCEDURE

Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 7 weeks of delay after the end of chemoradiotherapy

7 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Antoine Hospital - AP-HP, Department of general and digestive surgery

Paris, 75012, France

Location

Related Publications (2)

  • Lefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, Lupinacci R, Goasgen N, Parc Y, Simon T, Tiret E. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). J Clin Oncol. 2016 Nov 1;34(31):3773-3780. doi: 10.1200/JCO.2016.67.6049.

    PMID: 27432930DERIVED

  • Lefevre JH, Rousseau A, Svrcek M, Parc Y, Simon T, Tiret E; French Research Group of Rectal Cancer Surgery (GRECCAR). A multicentric randomized controlled trial on the impact of lengthening the interval between neoadjuvant radiochemotherapy and surgery on complete pathological response in rectal cancer (GRECCAR-6 trial): rationale and design. BMC Cancer. 2013 Sep 12;13:417. doi: 10.1186/1471-2407-13-417.

    PMID: 24028546DERIVED

Related Links

MeSH Terms

Conditions

Rectal NeoplasmsPathologic Complete Response

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jérémie Lefèvre, MD

    Assistance Publique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 24, 2012

Study Start

October 25, 2012

Primary Completion

October 22, 2015

Study Completion

May 6, 2020

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

FR(1)