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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Barcelona、スペイン、08003
- Hospital de Mar
-
Madrid、スペイン、28041
- Hospital Universitario 12 de Octubre
-
Madrid、スペイン、28040
- Hospital Universitario Clinico San Carlos
-
Madrid、スペイン、28007
- Hospital Universitario Gregorio Marañón
-
-
Andalucia
-
Granada、Andalucia、スペイン、18014
- Hospital Universitario Virgen de las Nieves
-
Málaga、Andalucia、スペイン、29010
- Hospital Regional Universitario de Málaga
-
Sevilla、Andalucia、スペイン、41014
- Hospital Universitario Virgen de Valme
-
-
Aragon
-
Zaragoza、Aragon、スペイン、50009
- Hospital Universitario Miguel Servet
-
-
Cantabria
-
Santander、Cantabria、スペイン、39008
- Hospital Universitario Marqués de Valdecilla
-
-
Castilla La Mancha
-
Toledo、Castilla La Mancha、スペイン、45004
- Hospital Virgen de la Salud
-
-
Castilla Y Leon
-
Salamanca、Castilla Y Leon、スペイン、37007
- Hospital Universitario De Salamanca
-
-
Cataluña
-
Badalona、Cataluña、スペイン、08916
- Institut Catalá d'Oncologia (ICO) BADALONA
-
Girona、Cataluña、スペイン、17007
- Institut Català d'Oncologia (ICO) Girona
-
Hospitalet de Llobregat、Cataluña、スペイン、08908
- Hospital Duran i Reynalds (ICO-Hospitalet)
-
-
Comunitat Valenciana
-
Valencia、Comunitat Valenciana、スペイン、46026
- Hospital Universitario y Politécnico La Fe
-
-
Galicia
-
A Coruña、Galicia、スペイン、15009
- Centro Oncologico de Galicia
-
Lugo、Galicia、スペイン、27003
- Hospital Universitario Lucus Augusti
-
-
Islas Baleares
-
Palma De Mallorca、Islas Baleares、スペイン、07120
- Hospital Universitario Son Espases
-
-
Navarra
-
Pamplona、Navarra、スペイン、31008
- Complejo Hospitalario Navarra (PAMPLONA)
-
-
Tenerife
-
San Cristobal de la Laguna、Tenerife、スペイン、38320
- Hospital Universitario Canarias (TENERIFE)
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free survival (PFS)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Best Overall Response (BOR)
時間枠：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
|
|
Overall Response Rate (ORR)
時間枠：Through study completion, average 1 year
|
Overall response rate, defined as the proportion of patients with CR or PR as BOR.
|
Through study completion, average 1 year
|
|
Disease Control Rate (DCR)
時間枠：Through study completion, average 1 year
|
The proportion of patients with CR, PR or SD as BOR.
|
Through study completion, average 1 year
|
|
Frequency of Adverse Events (AEs)
時間枠：Through study completion, average 1 year
|
Safety will be studied as function of AEs frequency: The number of adverse events classified by type and intensity
|
Through study completion, average 1 year
|
|
Overall survival (OS)
時間枠：Through study completion, average 1 year
|
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.
|
Through study completion, average 1 year
|
|
Relative dose intensity (RDI)
時間枠：Through study completion, average 1 year
|
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
|
Through study completion, average 1 year
|
|
Dose-related and compliance data
時間枠：Through study completion, average 1 year
|
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.
|
Through study completion, average 1 year
|
|
Duration of Response (DOR)
時間枠：Through study completion, average 1 year
|
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
|
|
Proportion of long disease-free survivors
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Beatriz Cirauqui Cirauqui, M.D. Ph.D.、Institut Catalá d'Oncologia (ICO) BADALONA
- 主任研究者：Jordi Rubió Casadevall, M.D. Ph.D.、Institut Català d'Oncologia (ICO) Girona
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TTCC-2019-02
- TTC-CET-2020-01 (その他の識別子：Agencia Española del Medicamento y Productos Sanitarios)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。