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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Barcelona, 스페인, 08003
- Hospital de Mar
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Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
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Madrid, 스페인, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, 스페인, 28007
- Hospital Universitario Gregorio Marañón
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Andalucia
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Granada, Andalucia, 스페인, 18014
- Hospital Universitario Virgen de las Nieves
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Málaga, Andalucia, 스페인, 29010
- Hospital Regional Universitario de Málaga
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Sevilla, Andalucia, 스페인, 41014
- Hospital Universitario Virgen de Valme
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Aragon
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Zaragoza, Aragon, 스페인, 50009
- Hospital Universitario Miguel Servet
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Cantabria
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Santander, Cantabria, 스페인, 39008
- Hospital Universitario Marqués de Valdecilla
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Castilla La Mancha
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Toledo, Castilla La Mancha, 스페인, 45004
- Hospital Virgen de la Salud
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Castilla Y Leon
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Salamanca, Castilla Y Leon, 스페인, 37007
- Hospital Universitario De Salamanca
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Cataluña
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Badalona, Cataluña, 스페인, 08916
- Institut Catalá d'Oncologia (ICO) BADALONA
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Girona, Cataluña, 스페인, 17007
- Institut Català d'Oncologia (ICO) Girona
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Hospitalet de Llobregat, Cataluña, 스페인, 08908
- Hospital Duran i Reynalds (ICO-Hospitalet)
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Comunitat Valenciana
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Valencia, Comunitat Valenciana, 스페인, 46026
- Hospital Universitario y Politécnico La Fe
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Galicia
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A Coruña, Galicia, 스페인, 15009
- Centro Oncologico de Galicia
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Lugo, Galicia, 스페인, 27003
- Hospital Universitario Lucus Augusti
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Islas Baleares
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Palma De Mallorca, Islas Baleares, 스페인, 07120
- Hospital Universitario Son Espases
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Navarra
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Pamplona, Navarra, 스페인, 31008
- Complejo Hospitalario Navarra (PAMPLONA)
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Tenerife
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San Cristobal de la Laguna, Tenerife, 스페인, 38320
- Hospital Universitario Canarias (TENERIFE)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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Weekly cetuximab at starting dose, that could be switched to biweekly
Paclitaxel at starting dose of 80 mg/m2
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free survival (PFS)
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Best Overall Response (BOR)
기간: Through study completion, average 1 year
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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.
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Through study completion, average 1 year
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Overall Response Rate (ORR)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: Through study completion, average 1 year
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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.
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Through study completion, average 1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Beatriz Cirauqui Cirauqui, M.D. Ph.D., Institut Catalá d'Oncologia (ICO) BADALONA
- 수석 연구원: Jordi Rubió Casadevall, M.D. Ph.D., Institut Català d'Oncologia (ICO) Girona
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TTCC-2019-02
- TTC-CET-2020-01 (기타 식별자: Agencia Española del Medicamento y Productos Sanitarios)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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