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Local Excision in Downstaged Rectal Cancer (GRECCAR 2)
This study is currently recruiting participants.
Verified by University Hospital, Bordeaux, May 2007
First Received: January 26, 2007   Last Updated: May 29, 2007   History of Changes
Sponsors and Collaborators: University Hospital, Bordeaux
Sanofi-Synthelabo
Hoffmann-La Roche
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00427375
  Purpose

Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant capecitabine 1600mg/m²/day and oxaliplatin 50mg/m²/week). Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years.


Condition Intervention Phase
Rectal Neoplasms
Procedure: local rectal excision
Procedure: total mesorectal excision
Phase III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Compare the proportion of patients presenting at least 1 component of the composite outcome (4 components: death, recurrence, major morbidity and severe after effects) at 2 years after [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect [ Time Frame: 24 months ]
  • 5-year survival. [ Time Frame: 5 years ]
  • Quality of life (QLQ C30 – CR38)

Estimated Enrollment: 300
Study Start Date: March 2007
Estimated Study Completion Date: March 2014
Detailed Description:

Rectal excision is the standard surgical treatment of rectal cancer. The risk of mortality and major short and long term morbidity induced by rectal excision justifies new treatments. Local excision is a conservative alternative approach associated with low mortality and morbidity. The purpose of this prospective randomised multicenter study is to compare local vs rectal excision in good responders after radiochemotherapy for low rectal cancer.

Patients with T2T3 low rectal cancer, less than 8 cm from the anal verge, size =< 4 cm, received neoadjuvant treatment, included radiotherapy 50Gy in 5 weeks with concomitant chemotherapy : capecitabine 1600mg/m²/j (5 days/7) and oxaliplatin 50mg/m²/weekly.

Good clinical responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. In case of not confirmed pathological response following local excision, complementary rectal excision is required.

Bad responders (residual tumour > 2cm) are treated by primary rectal excision. Follow-up includes digital rectal examination, CT-scan and endorectal ultrasound (if local excision) every 4 months for 2 years, then every 6 months for 3 years.

  Eligibility

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

Inclusion Criteria:

  • T2T3 adenocarcinoma of the rectum
  • Tumour size =< 4cm
  • Less than 8 cm from the anal verge
  • No metastatic disease
  • Patient is at least 18 years of age
  • ECOG performance status score =< 2
  • Patient and doctor have signed informed consent
  • inclusion criteria : Residual clinical tumour size =< 2cm after radiochemotherapy

Exclusion Criteria:

  • T1, T4 tumour or anal sphincter invasion
  • Metastatic disease (M1)
  • Contra indication for chemotherapy or radiotherapy
  • History of cancer
  • Symptomatic cardiac or coronary insufficiency
  • Severe renal insufficiency
  • Peripheral neuropathy
  • Patient included in a trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427375

Contacts
Contact: Eric RULLIER, Pr. (33) 5 56 79 58 10 eric.rullier@chu-bordeaux.fr

Locations
France
Service de chirurgie digestive - hôpital Saint André Recruiting
Bordeaux, France, 33076
Contact: Eric RULLIER, Pr.     (33) 5 56 79 58 10     eric.rullier@chu-bordeaux.fr    
Service de Chirurgie Digestive - Hôpital A. Michallon - Boulevard de la Chantourne Not yet recruiting
LA TRONCHE, France, 38700
Contact: Jean-Luc FAUCHERON, Pr.     (33) 4 76 76 55 26     JLFaucheron@chu-grenoble.fr    
Département de chirurgie oncologique - CRLC Val d'Aurelle Not yet recruiting
Montpellier, France, 34298
Contact: Philippe ROUANET, Pr.     (33) 4 67 61 31 14     philippe.rouanet@valdorel.fnclcc.fr    
Sponsors and Collaborators
University Hospital, Bordeaux
Sanofi-Synthelabo
Hoffmann-La Roche
Investigators
Principal Investigator: Eric RULLIER, Pr. CHU Bordeaux
Study Chair: Genevieve CHENE, Pr. CHU de Bordeaux
  More Information

No publications provided

Study ID Numbers: CHUBX 2006/03, 2005-025
Study First Received: January 26, 2007
Last Updated: May 29, 2007
ClinicalTrials.gov Identifier: NCT00427375     History of Changes
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Bordeaux:
Rectal cancer surgery
Neoadjuvant radiochemotherapy
Randomized clinical trial
Multicenter study

Study placed in the following topic categories:
Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Rectal Neoplasm
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on July 06, 2009