Locally advanced rectal cancer
Conditions
Brief summary
To evaluate if the addition of induction chemotherapy with FOLFOXIRI leads to a higher pathological complete response (pCR) rate and clinical complete response (cCR) rate at 1 year in patients with high-risk locally advanced rectal cancer compared to the currently available literature regarding high-risk locally advanced rectal cancer patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy
Detailed description
To determine the recurrence free survival, To determine the distant metastasis free survival, To determine the progression-free survival, To determine the disease-free survival, To determine the overall survival, To determine the radiological response after induction chemotherapy, To determine the radiological response after induction chemotherapy and chemoradiotherapy, To determine the pathological response as determined by Mandard grading system, To determine the toxicity related to the administration of induction chemotherapy, To determine the compliance related to the administration of induction chemotherapy, To determine the toxicity related to the administration of chemoradiotherapy, To determine the compliance related to the administration of chemoradiotherapy, To determine the number of patients undergoing surgery, To determine the type and extent of surgery after neoadjuvant therapy, To determine the major surgical complications rate, To determine the quality of life, To determine the cost-effectiveness and -utility, To systematically collect blood and tissue samples for future translational research
Interventions
Sponsors
Catharina Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate if the addition of induction chemotherapy with FOLFOXIRI leads to a higher pathological complete response (pCR) rate and clinical complete response (cCR) rate at 1 year in patients with high-risk locally advanced rectal cancer compared to the currently available literature regarding high-risk locally advanced rectal cancer patients treated with (chemo)radiotherapy alone or followed by consolidation chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the recurrence free survival, To determine the distant metastasis free survival, To determine the progression-free survival, To determine the disease-free survival, To determine the overall survival, To determine the radiological response after induction chemotherapy, To determine the radiological response after induction chemotherapy and chemoradiotherapy, To determine the pathological response as determined by Mandard grading system, To determine the toxicity related to the administration of induction chemotherapy, To determine the compliance related to the administration of induction chemotherapy, To determine the toxicity related to the administration of chemoradiotherapy, To determine the compliance related to the administration of chemoradiotherapy, To determine the number of patients undergoing surgery, To determine the type and extent of surgery after neoadjuvant therapy, To determine the major surgical complications rate, To determine the quality of life, To deter | — |
Countries
Netherlands
Outcome results
None listed