BridgeMD
Impact of Biweekly and Triweekly Dosing Regimens
EU CTIS ID: 2025-522305-38-00
What this study is testing
To compare Progression-Free Survival (PFS) data assessed by the investigator and based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1) when applying 2weeks (q2w) and 3weeks (q3w) FOLFIRI chemotherapy regimens in the first-line palliative treatment of metastatic colorectal carcinoma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- patients aged 18 years or older (no upper age limit)
- patients ineligible for targeted biological therapy (see table 8 in the detailed protocol) or patients who refuse targeted biological therapy
- histologically proven metastatic colorectal adenocarcinoma from the primary tumour
- consent to participate in the study
- ECOG performance score of 0-2
- normal haematological and organ functions (serum AST, GOT, GPT -and creatinine- below three times the upper limit of normal, serum bilirubin is below 5xULN, absolute neutrophil count is > 1,5G/L, platelet count >100 G/L; higher AST/GOT/GPT values are allowed in case of liver metastasis upon the investigator’s decision)
You likely can't join if
- previous systemic treatment for metastatic disease (adjuvant treatment if completed more than 6 months ago is allowed)
- history of hypersensitivity to study agents
- MSI-H tumors if there’s no contraindication to immunotherapy
- known complete DPD deficiency or UGT1A1 polymorphysm (screening is not part of the study due to access difficulties in routine clinical practice)
- patients who are expected to become eligible for targeted biological therapy after a certain period of time, and who receive FOLFIRI alone only at the beginning of the therapeutic sequence (e.g., in the postoperative period), are not eligible to participate in the study (targeted biological therapy administered in a later line of treatment is permitted within the study)
- patients eligible for conversion therapy (systemic treatment preceeding surgical resection of CRC metastases)
See the full eligibility criteria
- patients aged 18 years or older (no upper age limit)
- patients ineligible for targeted biological therapy (see table 8 in the detailed protocol) or patients who refuse targeted biological therapy
- histologically proven metastatic colorectal adenocarcinoma from the primary tumour
- consent to participate in the study
- ECOG performance score of 0-2
- normal haematological and organ functions (serum AST, GOT, GPT -and creatinine- below three times the upper limit of normal, serum bilirubin is below 5xULN, absolute neutrophil count is > 1,5G/L, platelet count >100 G/L; higher AST/GOT/GPT values are allowed in case of liver metastasis upon the investigator’s decision)
- disease measurable according to RECIST 1.1 and eligibility for delivering CT scan with contrast agents
- use of high efficacy contraception
- life expectancy of at least 3 months as judged by the treating physician
- molecular pathology testing of the tumor specimen (RAS/RAF status + MSI status)
- previous systemic treatment for metastatic disease (adjuvant treatment if completed more than 6 months ago is allowed)
- history of hypersensitivity to study agents
- MSI-H tumors if there’s no contraindication to immunotherapy
- known complete DPD deficiency or UGT1A1 polymorphysm (screening is not part of the study due to access difficulties in routine clinical practice)
- patients who are expected to become eligible for targeted biological therapy after a certain period of time, and who receive FOLFIRI alone only at the beginning of the therapeutic sequence (e.g., in the postoperative period), are not eligible to participate in the study (targeted biological therapy administered in a later line of treatment is permitted within the study)
- patients eligible for conversion therapy (systemic treatment preceeding surgical resection of CRC metastases)
- patients requiring rapid regression (preferentially treated with FOLFOX)
- oligometastatic disease where the tumor board indicates ablative local treatment of metastases
- severe organ dysfunction; severe internal or chronic infectious disease excluding oncology treatment; acute, severely symptomatic infectious disease within 2 weeks prior to treatment
- other treatment for oncological purposes within 4 weeks prior to treatment (palliative, decompressive or analgetic radiotherapy is allowed)
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.