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| ID | Type | Description | Link |
|---|---|---|---|
| AFLIBL07747 | Other Identifier | Sanofi | |
| U1111-1272-2417 | Registry Identifier | ICTRP |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorouracil | Drug | Pharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of resection rate (R0/R1) | R0 /R1 resection rate after aflibercept + FOLFIRI (resection with histological assessment of margin status) | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined starting from the date of the first aflibercept administration. | Up to 69 months |
| Progression-free surivival | 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) |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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The source population for this study will be patients treated with aflibercept in combination with FOLFIRI for metastatic ColoRectal Cancer (mCRC) after failure of an oxaliplatin-containing regimen (including patients pretreated with bevacizumab or anti-estimated glomerular filtration rate (anti-EGFR) and patients treated with oxaliplatin in the adjuvant setting but excluding these already participating in a clinical trial) recruited from particpating sites in France. The study will aim to enroll approximately 140 adult patients treated with aflibercept in combination with FOLFIRI for metastatic colorectal cancer after failure of an oxaliplatin-containing regimen from up to 30 sites.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39486163 | Background | Tougeron D, Bibeau F, Chibaudel B, Kim S, Nguyen T, Phelip JM, Mille D, Bouattour M, Tavan D, Rinaldi Y, Lecomte T, Perrier H, Spaeth D, Caroli Bosc FX, Metges JP, Ferec M, Hautefeuille V, Deslandres-Cruchant M, Danion J, Hammel P, Lewin M, Tasu JP, Angelergues A, DiFiore F, Evrard S, Mansar R, Caillou H, Geffriaud-Ricouard C, Adam R. Resection of colorectal liver metastases with second-line aflibercept plus FOLFIRI: Results from the RESECTION prospective French cohort. Eur J Cancer. 2024 Dec;213:115082. doi: 10.1016/j.ejca.2024.115082. Epub 2024 Oct 22. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| C533178 | aflibercept |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Aflibercept | Drug | Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion |
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| Irinotecan | Drug | Pharmaceutical Form: solution for injection Route of Administration: IV infusion |
|
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| Up to 69 months |
| Relapse-free surivial | 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) | Up to 69 months |
| Objective Response | Assessed according to RECIST and CHUN (radiological assessment) criteria in the exploratory analysis. | Up to 69 months |
| Conversion rate | Initially unresectable disease which became resectable after aflibercept + FOLFIRI, with R0/R1 resection). | Up to 69 months |
| Histological response of resected patients via Tumor Regression Grade (TRG) | Histological response of resected patients via TRG | Up to 69 months |
| Histological response of resected patients via Modified Tumor Regression Grade (mTRG) | Histological response of resected patients via mTRG, | Up to 69 months |
| Histoligical response of resected patients via Blazer assessment | Up to 69 months |
| 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 | Number of patients with serious and non-serious adverse events occurring during treatment | Up to 69 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006571 |
| Heterocyclic Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |