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 type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  National, multicentric, prospective, observational trial

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PANITUMUMAB

  CETUXIMAB

  FLUOROURACIL

  OXALIPLATIN

  LEVOLEUCOVORIN

  IRINOTECAN
• Medical condition to be studied:
  Colorectal cancer
• Additional medical condition(s):
  Metastatic colorectal cancer RAS wild-type

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with rat sarcoma virus (RAS) wild-type metastatic colorectal cancer receiving FOLFOX or FOLFIRI + anti-EGFR MAb as the first line treatment under routine clinical practice in around 33 Italian oncology centers between November 2015 and December 2019.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Colorectal cancer patients
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  Assess the impact of the treatment with FOLFOX or FOLFIRI plus anti-EGFR MAbs on patients’ health related quality of life (HRQoL), as measured by means of the EORTC – QLQC30 questionnaire
• Outcomes:
  EORTC – QLQC30 questionnaire scores, Impact of dermatological adverse events during the treatment on patients’ skin satisfaction as measured by DLQI * Tolerability of treatments*Adherence to treatment: dose delays, dose reductions, number of administered cycles, average relative dose intensity of every drug* Management of dermatological adverse events * Effect on skin-related QoL of preemptive vs reactive treatment of skin toxicities
• Data analysis plan:
  The absolute frequency and the percentage for the qualitative variables will be calculated, the standard deviation, the median, the minimum and the maximum will be used to summarize the quantitative variables. EORTC QLQ-C30 scores will be presented at baseline and at each time point, by treatment group, scores will be presented as a percentage of the scores reported as reference, comparisons of mean change from baseline to last study visit in quality of life scores between treatment groups will be made using a t-test, and differences in mean from baseline and last time point will be assessed with a paired t-test. The total DLQI score will be presented with statistics at baseline and at each time point. The mean change from baseline in DLQI score at the last study visit will be compared between treatment groups using a t-test.