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Local Excision in Downstaged Rectal Cancer

CompletedPhase 3

Sponsor: University Hospital, Bordeaux

Conditions: Rectal Neoplasms

Interventions: local rectal excision, total mesorectal excision

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (40)

Agen, France
Auxerre, France
Besançon, France
Bordeaux, France
Bordeaux, France
Bordeaux, France
Boulogne-Billancourt, France
Clermont-Ferrand, France
Clermont-Ferrand, France
Clichy, France
La Rochelle, France
La Tronche, France
Lille, France
Lyon, France
Lyon, France
Marseille, France
Marseille, France
Montpellier, France
Nantes, France
Nice, France
Nice, France
Nîmes, France
Paris, France
Paris, France
Paris, France
Paris, France
Paris, France
Pierre-Bénite, France
Rennes, France
Rennes, France
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