Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation.
Conditions
Brief summary
Survival with organ preservation, defined as a rectum intact, owing to: - no radical TME, - no locoregional regrowth unless amenable to limited curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma, or a stoma owing to toxicities and/or poor functional outcomes).
Detailed description
- Anorectal function: low anterior resection syndrome score (LARS score, appendix 2), - Quality of life : EORTC questionnaires QLQ CR-29 and C-30 (appendix 2), - Safety : toxicity grading of the National Cancer Institute (NCI-CTC v5.0), - Surgical complications: Clavien-Dindo Classification of surgical complications (appendix 3)., - Clinical complete response rates at 7 weeks after nCRT, - Local recurrence rate, Efficacy: overall survival (OS), disease-free survival (DFS), and metastasis-free survival (MFS) rates.
Interventions
DRUGFOLINATE DE CALCIUM AGUETTANT 100 mg
DRUGpoudre pour solution injectable
DRUGIRINOTECAN ACCORD 20 mg/mL
DRUGsolution à diluer pour perfusion
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival with organ preservation, defined as a rectum intact, owing to: - no radical TME, - no locoregional regrowth unless amenable to limited curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma, or a stoma owing to toxicities and/or poor functional outcomes). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Anorectal function: low anterior resection syndrome score (LARS score, appendix 2), - Quality of life : EORTC questionnaires QLQ CR-29 and C-30 (appendix 2), - Safety : toxicity grading of the National Cancer Institute (NCI-CTC v5.0), - Surgical complications: Clavien-Dindo Classification of surgical complications (appendix 3)., - Clinical complete response rates at 7 weeks after nCRT, - Local recurrence rate, Efficacy: overall survival (OS), disease-free survival (DFS), and metastasis-free survival (MFS) rates. | — |
Countries
France
Outcome results
None listed