Local Excision in Downstaged Rectal Cancer

Phase 3

Completed

• Conditions: Rectal Neoplasms

• Registration Number: NCT00427375
• Lead Sponsor: University Hospital, Bordeaux

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 Timeline

• Study First Submitted: 2007-01-26
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Study Start: 2007-03-05
• Primary Completion: 2014-12
• Study Completion: 2018-02-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (40)

Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet; 🇫🇷 Agen, France

Polyclinique Sainte marguerite; 🇫🇷 Auxerre, France

Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming; 🇫🇷 Besançon, France

Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron; 🇫🇷 Bordeaux, France

Service de chirurgie digestive - hôpital Saint André - 1 rue Jean Burguet; 🇫🇷 Bordeaux, France

Service de Chirurgie Oncologique - Institut Bergonié - 229, cours de l'Argonne; 🇫🇷 Bordeaux, France

Service de Chirurgie Digestive - Hôpital ambroise Paré - 9 avenue Charles de Gaulle; 🇫🇷 Boulogne Billancourt, France

Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU Clermont-Ferrand - Boulevard Léon Malfreyt; 🇫🇷 Clermont-Ferrand, France

Département de Radiothérapie - Centre Jean Perrin - 58 rue Montalembert; 🇫🇷 Clermont-Ferrand, France

Service de Chirurgie Générale et Digestive - Hôpital Beaujon - 100 boulevard du Général Leclerc; 🇫🇷 Clichy, France

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