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Completed

NCT Number: NCT02624895

ObservationaL Study on the Qol of RAS Wild-type mCRC Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Brescia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. EORTC QLQ C30 questionnaire score

    Time frame: 24 months

    -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

  2. QoL questionnaire DLQI questionnaire score

    Time frame: 24 months

    Skin satisfaction will be measured using the DLQI. The DLQI score will also be expressed as a percentage of the maximum possible score of 30. DLQI scores reported during the treatment will be also expressed as percentage of the DLQI scores reported at baseline.The measure unit is the answer score provided by the patient to the questions in the questionnaire

  3. %of enrolled subjects, experiencing a specific adverse event according to NCI CTC-AE version 4.0

    Time frame: 24 months

    Tolerability: The toxicity rate, defined as the percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event of any grade, according to CTCAE version 4.02.

  4. Recording of number of concomitant medications, to prevent or treat dermatological adverse events

    Time frame: 24 months

    Management of dermatological toxicity: concomitant medications, both topical and systemic, adopted to prevent or treat dermatological adverse events will be recorded. The measure is the number of topical and systemic treatment administered for skin toxicity management

  5. Time to onset of the dermtological toxicity

    Time frame: 24 months

    Tolerability: Times to onset of dermatological toxicities will be also described. The measure is the times elapsed untill adverse event is occurred (days)

  6. Dose reduction

    Time frame: 24 months

    To describe the adherence to the treatment in terms of dose reduction.The measure unit is Number of dose reduction occurred out of standard as per clinical practice treatment scheme.

  7. "number of administered cycles"

    Time frame: 24 months

    Evaluate the number of treatment cycles performed by the patients. The measure is the number of cycles administered as per clinical practice scheme indicated in the protocol, by each patient

  8. average relative dose intensity of every drug"

    Time frame: 24 months

    Will be evaluated the average dose administered to the patient under treatment the measure units are mg or mg/kg

Secondary outcomes

  1. Score scale on questionnaire answers

    Time frame: 24 months

    To investigate the impact of dermatological adverse events during the treatment with FOLFOX plus anti-EGFR MAbs on patients' skin satisfaction as measured by means of the Dermatology Life Quality Index (DLQI) questionnaire. The measure unit is the score coming from patient answer to questions in the questionnaire

  2. Number of cycles on treatment before and of treatment due to AE

    Time frame: 24 months

    To assess the tolerability of administered treatments The measure unit is the number of cycles on treatment before and of treatment due to AE

  3. dose delay

    Time frame: 24 months

    To describe the adherence to the treatment in terms of dose delays, - the measure unit is Number of dose delay occurred out of standard as per clinical practice treatment scheme

  4. Questionnaire score

    Time frame: 24 months

    To describe the management of dermatological adverse events to assess the effect on skin-related QoL of preemptive Vs reactive treatment of skin toxicities. The measure units is the questionnaire score coming from patient answer to relevant questionnaire administered.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Acronym: SILQ

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2015
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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