Local Excision in Downstaged Rectal Cancer (GRECCAR 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sanofi
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00427375
First received: January 26, 2007
Last updated: May 7, 2013
Last verified: May 2013

January 26, 2007
May 7, 2013
March 2007
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00427375 on ClinicalTrials.gov Archive Site
  • Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 5-year survival. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life (QLQ C30 - CR38) [ Time Frame: at 0, 4, 8 and 12 months ] [ Designated as safety issue: No ]
  • Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect
  • 5-year survival.
  • Quality of life (QLQ C30 – CR38)
Not Provided
Not Provided
 
Local Excision in Downstaged Rectal Cancer
Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. 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.

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 between 45-55Gy in 5 weeks with concomitant chemotherapy consist of at least, one fluoropyrimidine.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Rectal Neoplasms
  • Procedure: local rectal excision
    New surgical option in good responders after neoadjuvant treatment for low rectal cancer
  • Procedure: total mesorectal excision
    standard surgery
  • Experimental: 1
    New surgical option in good responders after neoadjuvant treatment for low rectal cancer
    Intervention: Procedure: local rectal excision
  • Active Comparator: 2
    Standard surgery
    Intervention: Procedure: total mesorectal excision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
148
December 2017
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • T2T3 low 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 radiotherapy and/or fluoropyrimidine use in chemotherapy
  • History of cancer
  • Symptomatic cardiac or coronary insufficiency
  • Severe renal insufficiency
  • Peripheral neuropathy
  • Patient included in a trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00427375
CHUBX 2006/03, 2005-025
Yes
University Hospital, Bordeaux
University Hospital, Bordeaux
  • Sanofi
  • Roche Pharma AG
Principal Investigator: Eric RULLIER, Pr. CHU Bordeaux
Study Chair: Genevieve CHENE, Pr. University Hospital, Bordeaux
University Hospital, Bordeaux
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP