Local Excision in Downstaged Rectal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

January 26, 2007

Last Updated Date

July 29, 2009

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00427375 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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)

Descriptive Information

Brief Title ^ICMJE

Local Excision in Downstaged Rectal Cancer

Official Title ^ICMJE

Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy

Brief Summary

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.

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 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Rectal Neoplasms

Intervention ^ICMJE

Procedure: local rectal excision
Procedure: total mesorectal excision

Study Arms / Comparison Groups

Experimental: New surgical option in good responders after neoadjuvant treatment for low rectal cancer
Active Comparator: Standard surgery

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

March 2014

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Eric RULLIER, Pr.

(33) 5 56 79 58 10

eric.rullier@chu-bordeaux.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00427375

Responsible Party

Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux

Study ID Numbers ^ICMJE

CHUBX 2006/03, 2005-025

Study Sponsor ^ICMJE

University Hospital, Bordeaux

Collaborators ^ICMJE

Sanofi-Synthelabo
Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:	Eric RULLIER, Pr.	CHU Bordeaux
Study Chair:	Genevieve CHENE, Pr.	University Hospital, Bordeaux

Information Provided By

University Hospital, Bordeaux

Verification Date

July 2009

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