Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
NCT03092518
Adenocarcinoma, Carcinoma
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT05606094
This study will be conducted to understand real-world treatment patterns, participant characteristics (demographic and clinico-pathological characteristics), clinical outcomes and safety of different treatment regimens, and healthcare resource utilization in East Asia for HER2-positive locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) in a real-world setting.
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Notify Me18 year and older
All sexes
Observational
Sichuan Cancer Hospital, Chengdu, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
°Progression on or within 6 months post neoadjuvant or adjuvant therapy is counted as "rapid progressor" in a neo-adjuvant/adjuvant setting, and thus equivalent to advanced/metastatic disease failing 1 LOT.
Exclusion criteria
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Percentage of participants receiving each regimen in each line of treatment (LOT) since 1st LOT initiation will be assessed. LOT is defined as one regimen, possibly a combination of several drugs, given from the date of initiation of each LOT until the treatment failed to control the disease, is not tolerated by the participant, at the time of disease relapse/progression or death.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Duration of Therapy (DoT) is defined as the length of time from initiation of each LOT to permanent discontinuation of the treatment.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Reasons for stopping treatments will be ascertained by patient charts and assessed by frequency and percentage.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Treatment sequencing from 1st LOT to 2nd LOT and to the subsequent LOT will be assessed.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Percentage of participants receiving locoregional treatment for localized disease and locoregional treatment for metastasis (radiotherapy and/or surgery) since 1st LOT initiation will be assessed.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Length of time from the date of initiation of LOT to the date of real-world disease progression or death due to any cause, whichever comes first.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Length of time from the date of initiation of LOT to death due to any cause.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Length of time from the initiation of LOT to the date of real-world disease progression, treatment discontinuation, or death due to any cause, whichever occurs first.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Length of time from the date the participant initiates the LOT to the date the participant discontinues that LOT or death due to any cause, whichever occurs first.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Length of time from the date the participant initiates the LOT to the date the participant initiates next LOT or death from any cause, whichever occurs first.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Proportion of participants who achieved real-world complete response or real-world partial response to treatment for each LOT.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Proportion of participants with real-world complete response, real-world partial response and real-world stable disease during treatment for each LOT.
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Time frame: From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months
Daiichi Sankyo Co., Ltd.
Industry
A Multinational, Multicenter, Non-Interventional, Retrospective, Observational, Real-World Study: Treatment Patterns in Patients With HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in East Asia (HER2+ GASTA Study)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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