Impact of Biweekly and Triweekly Dosing Regimens
Key facts
- Where
- Pécs, MagyarországSee the site
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
- Which best describes how well you can look after yourself and be active?
Where in Magyarország
- University of Pécs - Clinical Center Institute of OncotherapyPécs, MagyarországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Of Pecs
- Trial code
- EU 2025-522305-38-00
- Record updated
- 2025. július 18.
- Original description
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 carcinomaRead full original descriptionShow less
Impact of Biweekly and Triweekly Dosing Regimens on Progression-Free Survival in First-Line FOLFIRI Treatment of Metastatic Colorectal Cancer: A Non-Inferiority Study (FIR-DIR)
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
Inclusion: 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).
Exclusion: previous systemic treatment for metastatic disease (adjuvant treatment if completed more than 6 months ago is allowed); MSI-H tumors if there’s no contraindication to immunotherapy; 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); 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); history of hypersensitivity to study agents; oligometastatic disease where the tumor board indicates ablative local treatment of metastases; known complete DPD deficiency or UGT1A1 polymorphysm (screening is not part of the study due to access difficulties in routine clinical practice).