locally advanced rectal cancer (LARC)
Conditions
Brief summary
Pathologic complete response (pCR), defined as complete histological regression with no available tumor cells (yT0N0) in the intention-to-treat population
Detailed description
R0 resection rate (defined as the rate of microscopically margin-negative resections), Tumor downstaging rate (defined as the rate of reduction in the stage of the tumor as a result of therapy, from a more to a less threatening stage), Sphincter preservation rate (defined as the percentage of patients with preserved anorectal sphincter after surgery), Local recurrence rate (defined as the rate of detectable local disease at follow-up after study treatment completion), disease-free survival, overall survival
Interventions
DRUGTEMOZOLOMIDE
DRUGCAPECITABINE
Sponsors
Fondazione IRCCS Istituto Nazionale Dei Tumori
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR), defined as complete histological regression with no available tumor cells (yT0N0) in the intention-to-treat population | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate (defined as the rate of microscopically margin-negative resections), Tumor downstaging rate (defined as the rate of reduction in the stage of the tumor as a result of therapy, from a more to a less threatening stage), Sphincter preservation rate (defined as the percentage of patients with preserved anorectal sphincter after surgery), Local recurrence rate (defined as the rate of detectable local disease at follow-up after study treatment completion), disease-free survival, overall survival | — |
Countries
Italy
Outcome results
None listed