Colorectal Neoplasms, Metastatic Colorectal Cancer
Conditions
Brief summary
Primary Objective: -Evaluate the resection rate (R0/R1) in current practice for aflibercept in combination with irinotecan plus 5-fluorouracil (FOLFIRI) in patients treated for metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-containing regimen Secondary Objectives: * Evaluate overall survival, progression-free survival and relapse-free survival. * Evaluate conversion rates (initially unresectable disease which became resectable after chemotherapy, with R0/R1 resection). * Evaluate histological and radiological response rates. * Evaluate rate of postoperative complications. * Evaluate safety.
Detailed description
The estimated inclusion period is 45 months. Patient follow-up is 24 months and the total study duration is 69 months. Last patient status (alive or dead) collected before database lock.
Interventions
DRUGFluorouracil
Pharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion
DRUGAflibercept
Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion
DRUGIrinotecan
Pharmaceutical Form: solution for injection Route of Administration: IV infusion
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients treated with aflibercept in combination with FOLFIRI for mCRC after failure of an oxaliplatin-containing regimen (including patients pretreated with bevacizumab or anti-EGFR and patients treated with oxaliplatin in the adjuvant setting). * Exclusively or predominantly hepatic metastases (≤ 5 pulmonary nodules \< 2 cm). * Age \> 18 years. * Signed consent for collection of personal and medical data. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Exclusion criteria
* Concomitant participation in a clinical trial. * Patient receiving concomitant anti-VEGF agents and/or receiving aflibercept as part of a clinical trial or in a compassionate use program. * Patient receiving aflibercept in combination with chemotherapy other than FOLFIRI. * Patient with contra-indication to surgery. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of resection rate (R0/R1) | Up to 24 months | R0 /R1 resection rate after aflibercept + FOLFIRI (resection with histological assessment of margin status) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free surivival | Up to 69 months | Defined as the time from the date of the first aflibercept administration to the date of the first event (progression, relapse or death). (Relapse in case of complete response due to chemotherapy or surgery) |
| Relapse-free surivial | Up to 69 months | Defined as the time from the date of the first aflibercept administration to the date of the first event (progression, relapse or death). (Relapse in case of complete response due to chemotherapy or surgery) |
| Objective Response | Up to 69 months | Assessed according to RECIST and CHUN (radiological assessment) criteria in the exploratory analysis. |
| Conversion rate | Up to 69 months | Initially unresectable disease which became resectable after aflibercept + FOLFIRI, with R0/R1 resection). |
| Histological response of resected patients via Tumor Regression Grade (TRG) | Up to 69 months | Histological response of resected patients via TRG |
| Histological response of resected patients via Modified Tumor Regression Grade (mTRG) | Up to 69 months | Histological response of resected patients via mTRG, |
| Overall survival | Up to 69 months | Defined starting from the date of the first aflibercept administration. |
| Histological response of resected patients via modified Blazer assessment | Up to 69 months | — |
| Histological response of resected patients via Sebagh assessment | Up to 69 months | — |
| Radiological response for all patients using RECIST 1.1 criteria | Up to 69 months | — |
| Rate of 90-day postoperative complications using DINDO-CLAVIEN classification | Up to 69 months | — |
| Safety (serious and non-serious adverse events occurring during treatment | Up to 69 months | Number of patients with serious and non-serious adverse events occurring during treatment |
| Histoligical response of resected patients via Blazer assessment | Up to 69 months | — |
Outcome results
None listed