Overview

This trial is active, not recruiting.

Condition rectal neoplasms
Treatments local rectal excision, total mesorectal excision
Phase phase 3
Sponsor University Hospital, Bordeaux
Collaborator Sanofi
Start date March 2007
End date December 2014
Trial size 148 participants
Trial identifier NCT00427375, 2005-025, CHUBX 2006/03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
local rectal excision
New surgical option in good responders after neoadjuvant treatment for low rectal cancer
(Active Comparator)
Standard surgery
total mesorectal excision
standard surgery

Primary Outcomes

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

Secondary Outcomes

Measure
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)
time frame: at 0, 4, 8 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase III Randomized Trial of Local Excision Versus Total Mesorectal Excision in Downstaged T2T3 Low Rectal Cancer After Radiochemotherapy
Principal investigator Eric RULLIER, Pr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.