An observational study in Gastric Cancer and Gastroesophageal Junction Cancer, sponsored by AstraZeneca. Not yet recruiting. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by AstraZeneca · Observational
This is a prospective, non-interventional, observational, multicentre study evaluating the real-world effectiveness and safety of AstraZeneca-developed and approved medicines used to treat gastric and/or oesophageal cancers in Germany. The study is designed as an umbrella study comprising several drug- and indication-specific modules. The present description covers Module A, which evaluates durvalumab used perioperatively in combination with FLOT chemotherapy (D-FLOT), followed by adjuvant durvalumab monotherapy in adults with resectable gastric or gastro-oesophageal junction adenocarcinoma in routine clinical practice in Germany.
Eligible participants in Module A will be adult patients with histologically or cytologically confirmed, resectable adenocarcinoma of the stomach or gastroesophageal junction who have a documented decision to initiate perioperative treatment with durvalumab in combination with FLOT chemotherapy (D-FLOT), followed by adjuvant durvalumab monotherapy where applicable, in accordance with the applicable Summary of Product Characteristics (SmPC) and routine clinical practice in Germany. The decision to initiate D-FLOT must be made independently of study participation. Initiation of treatment with durvalumab and FLOT is an eligibility criterion for the study.
All diagnostic and treatment procedures, including the type and timing of surgery, treatment modifications and the frequency of routine clinical visits, will be at the discretion of the treating physician and will not be defined by the study protocol. No additional diagnostic or therapeutic procedures are mandated by the study. Data will be collected from medical records generated during routine clinical care and entered into the electronic case report form.
Approximately 300 eligible participants will be enrolled throughout Germany. Participants will be followed from initiation of perioperative D-FLOT for up to 36 months, or until death, withdrawal of informed consent, loss to follow-up, participation in an interventional clinical trial or initiation of subsequent systemic treatment for gastric or gastroesophageal junction cancer, whichever occurs first.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 300 is close to the median of 281 across 684 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with histologically confirmed of resectable adenocarcinoma of the stomach or of the gastroesophageal junction (GC/GEJC) with the decision to start perioperative treatment with D-FLOT according to marketing authorization being specified within the summary of product characteristics (SmPC) in routine clinical practice in Germany. (Modul A)
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Exclusion Criteria:
Real-world Event-free Survival at 24 Months (rwEFS24)
rwEFS24 is defined as the proportion of participants who are alive and event-free 24 months after initiation of perioperative D-FLOT. Real-world event-free survival is measured from the first dose of durvalumab in combination with FLOT until the first occurrence of disease progression during neoadjuvant treatment that precludes surgery or requires treatment other than D-FLOT, disease progression or recurrence during or after surgery, or death from any cause. Disease progression and recurrence will be assessed by the treating physician based on information available from routine clinical care. The outcome will be analysed using the Kaplan-Meier method in the Full Analysis Set. (Modul A)
Time frame: From the first dose of perioperative D-FLOT until 24 months after treatment initiation. (Modul A)
Baseline demographic, clinical and disease characteristics
Demographic, clinical and disease characteristics of participants receiving perioperative durvalumab plus FLOT will be described. Variables may include age, sex, ECOG performance status, comorbidities, Helicobacter pylori status, tumour histology, tumour localisation, clinical tumour stage and available biomarker results, including PD-L1, HER2, Claudin 18.2, MSI and MMR status. Continuous and categorical variables will be summarised descriptively, including the number of missing values. (Modul A)
Time frame: At baseline, before or at initiation of perioperative D-FLOT. (Modul A)
Proportion of participants reaching subsequent treatment phases
The proportion of participants reaching subsequent treatment phases will be described, including surgical resection, initiation of any adjuvant treatment, initiation of adjuvant durvalumab plus FLOT, and initiation of durvalumab monotherapy after adjuvant treatment. The number and percentage of participants reaching each treatment phase will be reported with appropriate confidence intervals. (Modul A)
Time frame: From initiation of perioperative D-FLOT until the end of the observation period, up to 36 months. (Modul A)
Pathological Complete Response Rate (pCR) (Modul A)
Pathological complete response is defined as the absence of detectable residual viable tumour cells in the primary tumour and resected lymph nodes at surgery, corresponding to tumour regression score 0 according to the local pathology assessment. The number and percentage of participants achieving a pathological complete response will be described. The pathological tumour regression score distribution may also be summarised where available.
Time frame: At surgery, approximately 8-12 weeks after initiation of perioperative D-FLOT, where applicable.
Completeness of surgical resection: R0, R1 and R2 resection rates (Modul A)
Completeness of resection will be described among participants who undergo surgical resection. R0 is defined as complete resection with negative margins, R1 as grossly complete resection with microscopically positive margins, and R2 as incomplete resection with macroscopically positive margins. The number and percentage of participants with R0, R1 and R2 resection will be reported. The proportions with R0 and R0/R1 resection may also be presented with appropriate confidence intervals.
Time frame: At surgery and the first post-surgery assessment, approximately 8-12 weeks after initiation of perioperative D-FLOT, where applicable.
Real-world Overall Survival (rwOS)
rwOS is defined as the time from the first dose of perioperative D-FLOT, consisting of durvalumab in combination with FLOT chemotherapy, until death from any cause. The proportions of participants alive at 6, 18, 24 and 36 months after treatment initiation will be estimated using the Kaplan-Meier method and presented with appropriate 95% confidence intervals. Participants without a documented death will be censored at the last date they were known to be alive. Cause of death may be described as disease-related, treatment-related, other or unknown, where information is available. (Modul A)
Time frame: From the first dose of perioperative D-FLOT until death or up to 36 months after treatment initiation. (Modul A)
Safety: Collection of Adverse Events (AE)
Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness.
Time frame: up to 36 months
No study locations are listed for this record.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Sep 2031, 58 months later.
Of 305 observational studies under Stomach Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 120. This study's planned 58 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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