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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- QoL questionnaire DLQI questionnaire score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients receiving a treatment under clinical investigation may not be included in the study
- •Previous treatment with an anti-EGFR monoclonal antibody
结局指标
主要结局
QoL questionnaire DLQI questionnaire score
时间窗: 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
EORTC QLQ C30 questionnaire score
时间窗: 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
%of enrolled subjects, experiencing a specific adverse event according to NCI CTC-AE version 4.0
时间窗: 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.
Time to onset of the dermtological toxicity
时间窗: 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)
Dose reduction
时间窗: 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.
"number of administered cycles"
时间窗: 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
average relative dose intensity of every drug"
时间窗: 24 months
Will be evaluated the average dose administered to the patient under treatment the measure units are mg or mg/kg
Recording of number of concomitant medications, to prevent or treat dermatological adverse events
时间窗: 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
次要结局
- Questionnaire score(24 months)
- Score scale on questionnaire answers(24 months)
- dose delay(24 months)
- Number of cycles on treatment before and of treatment due to AE(24 months)