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local excision, total mesorectal excision

Phase 3

Rectal Neoplasms | Unknown | Oncology |Sanofi|Trials Updated: Mar 14, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment148

FDA Designations

No designations recorded

local excision, total mesorectal excision clinical trials

local excision, total mesorectal excision · 1 trial · 1 indication

Phase 3 1
NCT00427375Local Excision in Downstaged Rectal CancerRectal Neoplasms
COMPLETED148 Analytics
PHASE3COMPLETED
Local Excision in Downstaged Rectal Cancer
Rectal Neoplasms
NCT00427375148
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALNew surgical option in good responders after neoadjuvant treatment for low rectal cancer
2ACTIVE_COMPARATORStandard surgery

Interventions

NameTypeDescription
local rectal excisionPROCEDURENew surgical option in good responders after neoadjuvant treatment for low rectal cancer
total mesorectal excisionPROCEDUREstandard surgery
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

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 : Residua...

Countries:France
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