Study identification

PURI

https://redirect.ema.europa.eu/resource/48557

EU PAS number

EUPAS44300

Study ID

48557

Official title and acronym

ProSpective MultIcenter ObservationaL Study on the Quality of Life of mCRC RAS Wild-type Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line of Treatment (20140383)

DARWIN EU® study

No

Study countries

Italy

Study description

This is a national, multicentric, prospective, observational trial to assess the impact of the treatment with FOLFOX or FOLFIRI plus anti-epidermal growth factor (EGFR) monoclonal antibodies (MAbs) on patients’ health related quality of life (HRQoL), as measured by means of the EORTC – QLQC30 questionnaire. It will include adult patients with rat sarcoma virus (RAS) wild-type metastatic colorectal cancer who are candidates to receive first-line FOLFOX or FOLFIRI + anti-EGFR MAb as per clinical practice in around 33 Italian centers. Each physician will see their patients within the context of routine visits, without any special visit being organized for the purposes of the study. EORTC QLQ-C30 and Dermatology Life Quality Index (DLQI) questionnaires will be completed by the patients at baseline, at the first day of every other cycle (every 2 weeks) thereafter, and “End of Study Visit” (within 28 days from the end of treatment with anti-EGFR or withdrawal from study for any reason).

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Multiple centres: 33 centres are involved in the study

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (742.96 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable