A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
연구 개요
상세 설명
Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. This prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced or recurrent/metastatic SCCHN treated with cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects, who are eligible for cetuximab treatment according to the indication in the approved label of cetuximab by Taiwan Health Authority. Data related to subjects' demographics, relevant tumor history, and laboratory information (hematology, biochemistry) will be captured and analyzed descriptively.
OBJECTIVES
Primary objective:
• To obtain safety information on the use of cetuximab in subjects with SCCHN according to the regulatory approved label and in a regular clinical setting
Secondary objectives:
• To gather clinical efficacy information of the treatment
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Tainan County
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Liouying, Tainan County, 대만
- Liouying Chi-Mei Hospital
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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:
- Histologically proven Stage 3-4 locally advanced SCCHN (oropharynx, hypopharynx, larynx) or recurrent and/or metastatic SCCHN
- Age greater than or equal to 18 years
- Signed informed consent
Exclusion Criteria:
- Subjects with known severe (Grade 3 or 4; National Cancer Institute Common Toxicity Criteria Version 4.03) hypersensitivity reactions to Cetuximab
- Subjects with contraindications for concomitantly used chemotherapeutic agents or radiation therapy, identified before initiation of cetuximab combination treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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비간섭 연구
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Subjects administered with Cetuximab, once weekly by intravenous infusion at a first dose of 400 milligram per square meter (mg/m^2) body surface area for 120 minutes infusion period and subsequently at a dose of 250 mg/m^2 for 60 minutes infusion period, will be observed.
The maximum infusion rate must not exceed 10 milligram per minute (mg/min).
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of adverse drug reactions and serious adverse drug reactions
기간: From the first infusion of cetuximab until three months after the last infusion of Cetuximab
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From the first infusion of cetuximab until three months after the last infusion of Cetuximab
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Number of subjects discontinuing the study due to intolerability of cetuximab
기간: From the first infusion of cetuximab until three months after the last infusion of Cetuximab
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From the first infusion of cetuximab until three months after the last infusion of Cetuximab
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable
기간: From the first infusion of cetuximab until three months after the last infusion of cetuximab
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From the first infusion of cetuximab until three months after the last infusion of cetuximab
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Time to progression
기간: From the first infusion of cetuximab until three months after the last infusion of cetuximab
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From the first infusion of cetuximab until three months after the last infusion of cetuximab
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Duration of response
기간: From the first infusion of cetuximab until three months after the last infusion of cetuximab
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From the first infusion of cetuximab until three months after the last infusion of cetuximab
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Overall Survival
기간: From the first infusion of cetuximab to death until three months after the last infusion of cetuximab
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From the first infusion of cetuximab to death until three months after the last infusion of cetuximab
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chao-Jung Tsao, Dr., Liouying Chi-Mei Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EMR62202-512
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