Metastatic Colorectal CancerNCT05178745
Resection Observatory
An observational study of Metastatic Colorectal Cancer and Colorectal Neoplasms, run by Sanofi.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Colorectal Neoplasms
- What is being tested?
- Fluorouracil, Aflibercept and Irinotecan
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2016to 27 May 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer, Colorectal Neoplasms
- Being tested
- Fluorouracil, Aflibercept, Irinotecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
Pharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion
AfliberceptDrug
Also called ZALTRAP®
Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion
IrinotecanDrug
Also called CAMPTOSAR®
Pharmaceutical Form: solution for injection Route of Administration: IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen Receives: Drug: Fluorouracil; Drug: Aflibercept; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of resection rate (R0/R1)
R0 /R1 resection rate after aflibercept + FOLFIRI (resection with histological assessment of margin status)
Measured: Up to 24 months
Secondary outcomes (13)
Overall survival
Defined starting from the date of the first aflibercept administration.
Measured: 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)
Measured: 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)
Measured: Up to 69 months
Objective Response
Assessed according to RECIST and CHUN (radiological assessment) criteria in the exploratory analysis.
Measured: Up to 69 months
Conversion rate
Initially unresectable disease which became resectable after aflibercept + FOLFIRI, with R0/R1 resection).
Measured: Up to 69 months
Histological response of resected patients via Tumor Regression Grade (TRG)
Histological response of resected patients via TRG
Measured: Up to 69 months
Histological response of resected patients via Modified Tumor Regression Grade (mTRG)
Histological response of resected patients via mTRG,
Measured: Up to 69 months
Histoligical response of resected patients via Blazer assessment
Measured: Up to 69 months
Histological response of resected patients via modified Blazer assessment
Measured: Up to 69 months
Histological response of resected patients via Sebagh assessment
Measured: Up to 69 months
Radiological response for all patients using RECIST 1.1 criteria
Measured: Up to 69 months
Rate of 90-day postoperative complications using DINDO-CLAVIEN classification
Measured: 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
Measured: Up to 69 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start7 Sep 2016
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178745
- Sponsor's protocol ID
- OBS15624
- Other IDs
- AFLIBL07747, U1111-1272-2417
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2021
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39486163
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
- ClinicalTrials.gov ID
- NCT05178745
- Acronym / sponsor ID
- OBS15624
- Conditions
- Metastatic Colorectal Cancer, Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2016 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Fluorouracil, Drug: Aflibercept, Drug: IrinotecanPatients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluorouracilPharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion | Drug | Cohort 1 |
| AfliberceptAlso: ZALTRAP®Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion | Drug | Cohort 1 |
| IrinotecanAlso: CAMPTOSAR®Pharmaceutical Form: solution for injection Route of Administration: IV infusion | Drug | Cohort 1 |
Primary outcome
Assessment of resection rate (R0/R1)
Time frame: Up to 24 months
R0 /R1 resection rate after aflibercept + FOLFIRI (resection with histological assessment of margin status)
13 secondary outcomes
Overall survival
Time frame: Up to 69 months
Progression-free surivival
Time frame: Up to 69 months
Relapse-free surivial
Time frame: Up to 69 months
Objective Response
Time frame: Up to 69 months
Conversion rate
Time frame: Up to 69 months
Histological response of resected patients via Tumor Regression Grade (TRG)
Time frame: Up to 69 months
Histological response of resected patients via Modified Tumor Regression Grade (mTRG)
Time frame: Up to 69 months
Histoligical response of resected patients via Blazer assessment
Time frame: Up to 69 months
Histological response of resected patients via modified Blazer assessment
Time frame: Up to 69 months
Histological response of resected patients via Sebagh assessment
Time frame: Up to 69 months
Radiological response for all patients using RECIST 1.1 criteria
Time frame: Up to 69 months
Rate of 90-day postoperative complications using DINDO-CLAVIEN classification
Time frame: Up to 69 months
Safety (serious and non-serious adverse events occurring during treatment
Time frame: Up to 69 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Background: PubMed 39486163Tougeron 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Colorectal Neoplasms, run by Sanofi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of resection rate (R0/R1) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05178745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.