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)

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

Multiple centres: 33 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 10/11/2014

Study start date

Planned: 30/12/2015

Actual: 30/12/2015

Data analysis start date

Planned: 13/08/2021

Actual: 13/08/2021

Date of final study report

Planned: 30/12/2021

Actual: 08/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original panitumumab 20140383

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable