Clinical trial · Observational
Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients
NCT04920747CI-TRIAL-00052200TandHERcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this retrospective study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Docetaxel | — | UNRESOLVED | — |
| HER2-positive Gastric Cancer | HER2-Positive Gastric Adenocarcinoma | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Trastuzumab | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Taxane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- S group
- description
- platin-5FU + trastuzumab
- label
- T group
- description
- taxanes + platin-5FU + trastuzumab
- interventionNames
- Drug: Taxane
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- up to 12 years
- description
- PFS will be defined as the time interval between the date of randomization and the date of first progression (local, regional, metastatic, second cancer) or death regardless of the cause. Patients alive without progression will be censored at the time of the latest news
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed non-resectable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-esophageal junction; * tumor samples scored as 3+ on immunohistochemistry or FISH (Fluorescence in situ Hybridization) positive (HER2:CEP17 ratio ≥2); * measurable disease; * treated by trastuzumab, platin (cisplatine or oxaliplatine), fluoropyrimidine (5-FU or capecitabine) +/- taxanes (docetaxel or paclitaxel), * as first-line therapy for advanced gastric cancer. Exclusion Criteria: * previous chemotherapy by taxane for metastatic disease, * previous anti-HER2 therapy.
References
Publications (1)
- DERIVEDOrillard E, Henriques J, Vernerey D, Almotlak H, Calcagno F, Fein F, Fratte S, Jary M, Klajer E, Vienot A, Borg C, Kim S. Interest of the Addition of Taxanes to Standard Treatment in First-Line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients. Front Oncol. 2022 Mar 7;12:763926. doi: 10.3389/fonc.2022.763926. eCollection 2022. PMID 35340264