Clinical trial · Observational
ObservationaL Study on the Qol of RAS Wild-type mCRC Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a national, multicentric, prospective, observational trial. The decision to prescribe FOLFOX or FOLFIRI plus panitumumab or FOLFOX or FOLFIRI plus cetuximab must have been freely taken by the clinician prior to the study entry for each patient included. Each physician will see his/her patients within the context of routine visits, without any special visit being organised for the purposes of the study. Therefore, the doctor-patient relationship and patient follow-up are not modified. Physicians are totally free to decide on their patients' therapeutic management. EORTC QLQ-C30 and DLQI questionnaires will be completed by the patients at baseline (Day 1 of Cycle 1), at the first day of every other cycle (every 2 weeks) thereafter, and at ""End of Study Visit" (within 28 days from the end of treatment with anti-EGFR or withdrawal from study for any reason). Before every cycle, adverse events will be recorded and graded according to NCI CTCAE v4.0. Treatment's modifications in terms of cycles' delay, dose reductions or drugs' interruptions will be recorded. Concomitant approaches to prevent or treat dermatological toxicities during the treatment will be registered.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- mCRC: Anti-EGFR MAbs + FOLFOX 1st line
- description
- • Adult (\>= 18 years old) RAS wild-type metastatic colorectal cancer patients candidate to receive FOLFOX plus panitumumab or FOLFOX plus cetuximab as upfront treatment as per clinical practice.
- label
- mCRC: Anti EGFR MAbs + FOLFIRI 1st line
- description
- Adults (\>= 18 years old) RAS wild-type metastatic colorectal cancer patients candidate to receive FOLFIRI plus panitumumab or FOLFIRI plus cetuximab as upfront treatment as per clinical practice
Primary outcomes (8)
- measure
- EORTC QLQ C30 questionnaire score
- timeFrame
- 24 months
- description
- -HRQoL will be measured using the EORTC QLQ-C30 questionnaire. EORTC QLQ-C30 scores reported during the treatment will be also expressed as percentage of the scores reported at baseline. The measure unit is the answer score provided by the patient to the questions in the questionnaire
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:- Adult (\>= 18 years old) RAS wild-type metastatic colorectal cancer patients candidate to receive FOLFOX or FOLFIRI plus panitumumab or FOLFOX or FOLFIRI plus cetuximab as upfront treatment as per clinical practice * Willingness and ability to comply with the protocol * Written informed consent to study procedures * Exclusion Criteria: - Patients receiving a treatment under clinical investigation may not be included in the study * Previous treatment with an anti-EGFR monoclonal antibody
References
Publications (0)
Data not yet available