Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients

NCT ID: NCT04920747

Last Updated: 2021-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Studies have reported a beneficial role of trastuzumab combined to platin-5-FU based chemotherapy in first-line advanced HER2 positive gastroesophageal adenocarcinoma. However, the effect of taxanes combined with platin-5FU + trastuzumab (TPFT) is understudied.

In this context, the aim of this study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.

Conditions

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HER2-positive Gastric Cancer Metastatic Cancer Docetaxel Trastuzumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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S group

platin-5FU + trastuzumab

No interventions assigned to this group

T group

taxanes + platin-5FU + trastuzumab

Taxane

Intervention Type DRUG

docetaxel or paclitaxel

Interventions

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Taxane

docetaxel or paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Besancon

Besançon, Franche-Comté, France

Site Status

Countries

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France

References

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Orillard 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.

Reference Type DERIVED
PMID: 35340264 (View on PubMed)

Other Identifiers

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2021/622

Identifier Type: -

Identifier Source: org_study_id

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