Status:
COMPLETED
Local Excision in Downstaged Rectal Cancer
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Sanofi
Roche Pharma AG
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 v...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2018
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00427375
Start Date
March 5 2007
End Date
February 8 2018
Last Update
March 14 2018
Active Locations (40)
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1
Centre Radiothérapie Oncologie Moyenne Garonne - 13 Quai du Docteur Calabet
Agen, France, 47000
2
Polyclinique Sainte marguerite
Auxerre, France, 89000
3
Service de Chirurgie Viscérale, Digestive et Cancérologique - CHRU J.Minoz - Boulevard Fleming
Besançon, France, 25030
4
Service de Radiothérapie - Clinique Tivoli - 220 rue Mandron
Bordeaux, France, 33000