Impact of Biweekly and Triweekly Dosing Regimens

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Pecs

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-07-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety, Dose response

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

Secondary objectives 3

1. To compare Overall Survival (OS) data between the q2w and q3w chemotherapy regimens
2. To compare the Time on Treatment (ToT) periods between the q2w and q3w chemotherapy regimens
3. Safety and tolerability of q3w FOLFIRI chemotherapy regimen comparing to q2w regimen

Conditions and MedDRA coding

Metastatic colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. patients aged 18 years or older (no upper age limit)
2. histologically proven metastatic colorectal adenocarcinoma from the primary tumour
3. consent to participate in the study
4. ECOG performance score of 0-2
5. 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)
6. disease measurable according to RECIST 1.1 and eligibility for delivering CT scan with contrast agents
7. use of high efficacy contraception
8. life expectancy of at least 3 months as judged by the treating physician
9. molecular pathology testing of the tumor specimen (RAS/RAF status + MSI status)
10. patients ineligible for targeted biological therapy (see table 8 in the detailed protocol) or patients who refuse targeted biological therapy

Exclusion criteria 10

1. previous systemic treatment for metastatic disease (adjuvant treatment if completed more than 6 months ago is allowed)
2. MSI-H tumors if there’s no contraindication to immunotherapy
3. known complete DPD deficiency or UGT1A1 polymorphysm (screening is not part of the study due to access difficulties in routine clinical practice)
4. 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)
5. patients eligible for conversion therapy (systemic treatment preceeding surgical resection of CRC metastases)
6. patients requiring rapid regression (preferentially treated with FOLFOX)
7. oligometastatic disease where the tumor board indicates ablative local treatment of metastases
8. severe organ dysfunction; severe internal or chronic infectious disease excluding oncology treatment; acute, severely symptomatic infectious disease within 2 weeks prior to treatment
9. other treatment for oncological purposes within 4 weeks prior to treatment (palliative, decompressive or analgetic radiotherapy is allowed)
10. history of hypersensitivity to study agents

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-Free Survival (PFS) assessed by the investigators

Secondary endpoints 3

1. Overall Survival (OS) data in both treatment arms
2. Time on treatment (ToT) periods in both treatment arms
3. AE, SAE events by CTCAE v.5.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Pecs

Sponsor organisation

University Of Pecs

Address

Edesanyak Utja 17

City

Pecs

Postcode

7624

Country

Hungary

Scientific contact point

Organisation

University Of Pecs

Contact name

Laszlo Mangel

Public contact point

Organisation

University Of Pecs

Contact name

Laszlo Mangel

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications