Rectal cancer
Conditions
Brief summary
disease-free survival in the intention-to-treat population
Detailed description
Disease-free survival, Overall survival, Quality of life, In addition to intention-to-treat analysis to estimate the effect size, also a per-protocol analysis (for pure treatment effect) will be carried out for disease-free survival and overall survival, The results of the ctDNA analysis of the blood samples taken at the first follow-up of the randomised patients who were ctDNA positive after surgery will be compared between the patients who received adjuvant chemotherapy and those who did not., Within the group of patients with de-tectable ctDNA after surgery, the pro-portion of patients with detectable ctDNA in the peripheral blood at the timing of detection of recurrent dis-ease on imaging will be assessed.
Interventions
DRUGFLUOROURACIL
DRUGCAPECITABINE
DRUGOXALIPLATIN
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival in the intention-to-treat population | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival, Overall survival, Quality of life, In addition to intention-to-treat analysis to estimate the effect size, also a per-protocol analysis (for pure treatment effect) will be carried out for disease-free survival and overall survival, The results of the ctDNA analysis of the blood samples taken at the first follow-up of the randomised patients who were ctDNA positive after surgery will be compared between the patients who received adjuvant chemotherapy and those who did not., Within the group of patients with de-tectable ctDNA after surgery, the pro-portion of patients with detectable ctDNA in the peripheral blood at the timing of detection of recurrent dis-ease on imaging will be assessed. | — |
Countries
Netherlands
Outcome results
None listed