Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN: Real World Data.
Retrospective Study With Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN (Squamous Cell Carcinoma of the Head and Neck): Real World Data.
Retrospective observational study that aims to collect real world data on the cetuximab plus paclitaxel regimen as first line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Assignment of a patient to a specific therapeutic strategy has been already decided in the past according to normal routine clinical practice; the decision to prescribe a specific treatment (between January 2012 and December 2018) was clearly dissociated from the decision to include a patient in the present study.
The investigators will retrospectively collect the information for 500 patients diagnosed with recurrent and/or metastatic SCCHN treated with a cetuximab plus paclitaxel regimen as first line for unresectable recurrent and/or metastatic disease, starting treatment with the defined cetuximab plus paclitaxel regimen, in 20 hospital members of the "Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC)", who express consent to participate in the study or have not explicitly withheld consent for use of their data. The information from the patients' medical records will be collected through the online database of the TTCC Group.
研究概览
详细说明
Retrospective observational study that aims to collect real world data on the cetuximab plus paclitaxel regimen as first line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) with the restriction that the data collection will only be clinical data from patients who received paclitaxel 80 mg/m2 as a starting dose with weekly cetuximab that could have been switched to biweekly during the maintenance phase.
The main objective will be to estimate the Progression-free survival (PFS) in patients treated with paclitaxel 80 mg/m2 as a starting dose, with weekly cetuximab that could have been switched to biweekly during the maintenance phase, as first line for recurrent and/or metastatic SCCHN.
Secondary objectives include:
To determine the Overall Response Rate (ORR), Best Overall Response (BOR), Disease Control Rate (DCR), overall survival (OS), duration of response (DoR), and safety in patients treated with the defined cetuximab plus paclitaxel regimen.
To evaluate the percentage of long disease-free survivors (defined as patients disease-free and alive at 2 years), and evaluate the percentage of long non-disease-free survivors (defined as patients not disease free, but alive at 2 years.
Analyses of patient outcomes by prognostic subgroups.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Barcelona、西班牙、08003
- Hospital de Mar
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Madrid、西班牙、28041
- Hospital Universitario 12 de Octubre
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Madrid、西班牙、28040
- Hospital Universitario Clinico San Carlos
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Madrid、西班牙、28007
- Hospital Universitario Gregorio Marañón
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Andalucia
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Granada、Andalucia、西班牙、18014
- Hospital Universitario Virgen de las Nieves
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Málaga、Andalucia、西班牙、29010
- Hospital Regional Universitario de Málaga
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Sevilla、Andalucia、西班牙、41014
- Hospital Universitario Virgen de Valme
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Aragon
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Zaragoza、Aragon、西班牙、50009
- Hospital Universitario Miguel Servet
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Cantabria
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Santander、Cantabria、西班牙、39008
- Hospital Universitario Marqués de Valdecilla
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Castilla La Mancha
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Toledo、Castilla La Mancha、西班牙、45004
- Hospital Virgen de la Salud
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Castilla Y Leon
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Salamanca、Castilla Y Leon、西班牙、37007
- Hospital Universitario De Salamanca
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Cataluña
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Badalona、Cataluña、西班牙、08916
- Institut Catalá d'Oncologia (ICO) BADALONA
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Girona、Cataluña、西班牙、17007
- Institut Català d'Oncologia (ICO) Girona
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Hospitalet de Llobregat、Cataluña、西班牙、08908
- Hospital Duran i Reynalds (ICO-Hospitalet)
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Comunitat Valenciana
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Valencia、Comunitat Valenciana、西班牙、46026
- Hospital Universitario y Politécnico La Fe
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Galicia
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A Coruña、Galicia、西班牙、15009
- Centro Oncologico de Galicia
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Lugo、Galicia、西班牙、27003
- Hospital Universitario Lucus Augusti
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Islas Baleares
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Palma De Mallorca、Islas Baleares、西班牙、07120
- Hospital Universitario Son Espases
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Navarra
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Pamplona、Navarra、西班牙、31008
- Complejo Hospitalario Navarra (PAMPLONA)
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Tenerife
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San Cristobal de la Laguna、Tenerife、西班牙、38320
- Hospital Universitario Canarias (TENERIFE)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with histologically confirmed recurrent and/or metastatic head and neck squamous-cell carcinoma including oral cavity, oropharynx, hypopharynx and larynx.
Note: Histological confirmation is required at the diagnosis of the primary. Not for recurrence and/or metastatic stages when radiological or clinical confirmation is valid
- Patients who received at least one dose of both paclitaxel 80 mg/m2 as a starting dose with weekly cetuximab, that could have been switched to biweekly during the maintenance phase, as a first line regimen in recurrent and/or metastatic disease.
- Start of first cycle of paclitaxel plus cetuximab between 1 January 2012, and 31 December 2018.
- Aged ≥ 18 years at the time of diagnosis of R/M SCCHN.
Voluntary written consent, if applicable*
- Note: Waiver of consent could be acceptable after all reasonable efforts and procedures have been followed and exhausted, and when an explicit refusal to sign the informed consent or refusal for use of data, or a revocation of consent by the patient has not been obtained.
Exclusion Criteria:
- Patients with histologically confirmed R/M SCCHN, who have also an unknown primary tumor or nasopharyngeal cancer or a non-squamous head & neck cancer.
- Patients who received the paclitaxel and cetuximab regimen for the first time in recurrent and/or metastatic disease as a second or subsequent line.
- Eastern Cooperative. Oncology Group (ECOG) performance status > 2.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Recurrent and/or metastatic SCCHN
Patients who received at least one dose of both paclitaxel 80 mg/m2 as a starting dose with weekly cetuximab, that could have been switched to biweekly during the maintenance phase, as a first line regimen in recurrent and/or metastatic disease.
|
Weekly cetuximab at starting dose, that could be switched to biweekly
Paclitaxel at starting dose of 80 mg/m2
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free survival (PFS)
大体时间：Through study completion, average 1 year
|
The PFS time is defined as the time from start of study treatment (first administration of cetuximab or paclitaxel) to the date of progression or death, whichever occurs first.
In patients without a PFS event, the PFS time will be censored on the date of the last radiological evaluation or on the date of the last study treatment received if the tumor response has not been evaluated after start of study treatment.
If no PFS was observed prior to start of second line treatment, then the PFS time will be censored at the first date of second line treatment.
|
Through study completion, average 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Best Overall Response (BOR)
大体时间：Through study completion, average 1 year
|
Best overall response during study treatment with the categories complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not available (NA), as assessed by the responsible physician.
The method used to assess BOR (e.g.
RECIST and version) will be also recorded.
|
Through study completion, average 1 year
|
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Overall Response Rate (ORR)
大体时间：Through study completion, average 1 year
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Overall response rate, defined as the proportion of patients with CR or PR as BOR.
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Through study completion, average 1 year
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Disease Control Rate (DCR)
大体时间：Through study completion, average 1 year
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The proportion of patients with CR, PR or SD as BOR.
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Through study completion, average 1 year
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Frequency of Adverse Events (AEs)
大体时间：Through study completion, average 1 year
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Safety will be studied as function of AEs frequency: The number of adverse events classified by type and intensity
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Through study completion, average 1 year
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Overall survival (OS)
大体时间：Through study completion, average 1 year
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Defined as time from start of study treatment until date of death due to any cause.
In patients without death the OS time is censored at the last date known to be alive.
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Through study completion, average 1 year
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Relative dose intensity (RDI)
大体时间：Through study completion, average 1 year
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Relative dose intensity (RDI) defined as amount of drug administered per unit of time expressed as the fraction of that defined in the standard regimen
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Through study completion, average 1 year
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Dose-related and compliance data
大体时间：Through study completion, average 1 year
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Frequency and magnitude of dose interruptions, dose modifications and discontinuation of treatment classified by the cause of discontinuation including adverse events, relapse, medical decision, patient decision, death and loss of follow-up.
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Through study completion, average 1 year
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Duration of Response (DOR)
大体时间：Through study completion, average 1 year
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Defined as the time from the first occurrence of PR or CR as BOR until PD or death, whichever occurs first in patients with CR or PR as BOR. The censoring rules specified for PFS will be also applied for duration of response. |
Through study completion, average 1 year
|
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Proportion of long disease-free survivors
大体时间：Through study completion, average 1 year
|
The proportion of patients alive and disease-free at 2 years after start of study treatment.
Only disease-free patients under first line treatment should be counted.
|
Through study completion, average 1 year
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合作者和调查者
调查人员
- 首席研究员：Beatriz Cirauqui Cirauqui, M.D. Ph.D.、Institut Catalá d'Oncologia (ICO) BADALONA
- 首席研究员：Jordi Rubió Casadevall, M.D. Ph.D.、Institut Català d'Oncologia (ICO) Girona
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- TTCC-2019-02
- TTC-CET-2020-01 (其他标识符：Agencia Española del Medicamento y Productos Sanitarios)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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