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New treatment option for Colorectal Cancer
Official title Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI
ClinicalTrials.gov ID: NCT06501482
What this study is testing
What is Postoperative reintroduction of FOLFIRI based chemotherapy?
Postoperative reintroduction of FOLFIRI based chemotherapy is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Eligible patients are patients with contraindication to preoperative oxaliplatin based-chemotherapy who underwent resection of no more than 10 colorectal liver metastases after preoperative FOLFIRI based chemotherapy with or without targeted agents. These patients must have objective response to treatment (radiologic or pathologic response).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for...
- No more than 10 treated CLM at surgery
- At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy.
- Preoperative FOLFIRI based chemotherapy ± targeted therapy administered no more than 12 weeks before surgery
- R0/R1resection ± radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease
You likely can't join if
- Palliative/R2 resection of CLM
- 10 lesions or more treated at the time of surgery
- Patients undergoing only radiofrequency ablation of all liver deposit (this situation precludes the assessment of pathologic response to preoperative...
- Extra-hepatic or residual metastasis of CRC
- Absence of objective response to therapy (radiological or pathological response )
- Inflammatory bowel disease
See the full eligibility criteria
- Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or side effects reasons. For this study, metachronous CLM is...
- No more than 10 treated CLM at surgery
- At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy.
- Preoperative FOLFIRI based chemotherapy ± targeted therapy administered no more than 12 weeks before surgery
- R0/R1resection ± radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease
- Objective response to preoperative therapy defined as complete or partial radiological response and/or major or complete pathologic response
- No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery. 1 non-specific lung nodule of less than 10 mm in maximum diameter is not considered as...
- Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status
- No contraindication to FOLFIRI based chemotherapy
- Patients must be 18 years old or older
- A WHO performance status of 0 or 1
- Participants must be affiliated to a social security scheme
- Palliative/R2 resection of CLM
- 10 lesions or more treated at the time of surgery
- Patients undergoing only radiofrequency ablation of all liver deposit (this situation precludes the assessment of pathologic response to preoperative chemotherapy)
- Extra-hepatic or residual metastasis of CRC
- Absence of objective response to therapy (radiological or pathological response )
- Inflammatory bowel disease
- Known UGT1A1\ 28 allele homozygosity
- complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng/ml
- Contraindications to investigational medicinal products (irinotecan, 5-FU, folinic acid) and to auxiliary medicinal products (ondansetron, methylprednisolone)
- Persistent toxicity ≥ grade 1 related to preoperative FOLFIRI based chemotherapy
- Known pregnancy (pregnancy test for women of childbearing) or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.