Local Excision in Downstaged Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Procedure: local rectal excision
* Procedure: total mesorectal excision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>New surgical option in good responders after neoadjuvant treatment for low rectal cancer | Procedure: local rectal excision<br>* New surgical option in good responders after neoadjuvant treatment for low rectal cancer<br>|
| Active Comparator: 2<br>Standard surgery | Procedure: total mesorectal excision<br>* standard surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the incidence at 2 years of each component separately: death, recurrence, major morbidity and severe after effect |  | 24 months | 
| 5-year survival. |  | 5 years | 
| Quality of life (QLQ C30 - CR38) |  | at 0, 4, 8 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer surgery, Neoadjuvant radiochemotherapy, Randomized clinical trial, Multicenter study