Recurrent rectal cancer after local excision, Rectal cancer
Conditions
Brief summary
Proportion of curative surgery (R0 resection)
Detailed description
3-year Disease Free and 3-year Overall Survival, Surgical morbidity and mortality (Dindo classification) during first 30 days after the surgery, Compliance to treatment: proportion of patients receiving full allocated neoadjuvant treatment, Proportion of good tumor response: LRRC with a decreasing size of 50% after preoperative treatment (defined as good MRI radiological responders according to previous data in the literature), Proportion of treatment related toxicity using International Common Terminology Criteria for Adverse Events (CTCAE) grading system v5.0, Quality of life (QLQ-C30 and QLQ-CR29) before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery
Interventions
DRUGCAMPTO 20 mg/mL
DRUGsolution à diluer pour perfusion (IV)
DRUGsolution injectable
DRUGsolution à diluer pour perfusion
Sponsors
Centre Hospitalier Universitaire De Bordeaux
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of curative surgery (R0 resection) | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year Disease Free and 3-year Overall Survival, Surgical morbidity and mortality (Dindo classification) during first 30 days after the surgery, Compliance to treatment: proportion of patients receiving full allocated neoadjuvant treatment, Proportion of good tumor response: LRRC with a decreasing size of 50% after preoperative treatment (defined as good MRI radiological responders according to previous data in the literature), Proportion of treatment related toxicity using International Common Terminology Criteria for Adverse Events (CTCAE) grading system v5.0, Quality of life (QLQ-C30 and QLQ-CR29) before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery | — |
Countries
France
Outcome results
None listed