Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
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:
Cohort 1 and 2:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
- Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Cohort 3:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC not earlier than October 2013
- Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Exclusion Criteria:
- Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.
Other Inclusion/Exclusion criteria may apply
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 |
---|
LD-SCLC receiving 1st line treatment
patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment
|
ED-SCLC receiving 1st line treatment
patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment
|
relapsed/refractory receiving 2nd or later-line treatment
relapsed/refractory patients receiving second- or later-line treatment
|
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 |
---|---|---|
Distribution of Patient Demographic Characteristics
時間枠:At baseline
|
Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors |
At baseline
|
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
時間枠:At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
時間枠:At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
時間枠:At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
Distribution of treatment patterns in patients with ED-SCLC
時間枠:Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
Distribution of treatment patterns in patients with LD-SCLC
時間枠:Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
時間枠:Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Composite of SCLC-related healthcare resource utilization (HCRU)
時間枠:Approximately 44 months
|
HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
|
Approximately 44 months
|
Overall survival (OS)
時間枠:Approximately 44 months
|
Approximately 44 months
|
|
Progression-free survival (PFS)
時間枠:Approximately 44 months
|
Approximately 44 months
|
|
Objective response rate (ORR)
時間枠:Approximately 44 months
|
Approximately 44 months
|
|
Mortality rate
時間枠:Approximately 44 months
|
Approximately 44 months
|
|
Treatment-related adverse events (AEs) leading to discontinuation
時間枠:Approximately 44 months
|
Approximately 44 months
|
|
Incidence of surgery as cancer-directed therapy
時間枠:Approximately 44 months
|
To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
Incidence of radiation therapy as cancer-directed therapy
時間枠:Approximately 44 months
|
To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
Incidence of best supportive care (BSC)
時間枠:Approximately 44 months
|
To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
Incidence of palliative care
時間枠:Approximately 44 months
|
To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
協力者と研究者
スポンサー
出版物と役立つリンク
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
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。
肺癌の臨床試験
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