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

Completed

• Conditions: Trastuzumab; HER2-positive Gastric Cancer; Metastatic Cancer; Docetaxel
• Interventions: Drug: Taxane

• Registration Number: NCT04920747
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Last Update Submitted: 2021-06-04
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T group	Taxane	taxanes + platin-5FU + trastuzumab

Primary Outcome Measures

Name	Time	Method
Progression free survival	up to 12 years	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 Outcome Measures

Name	Time	Method
Overall survival	up to 12 years	OS will be calculated between the date of randomization and the date of death from any cause. . Alive patients or lost to follow-up at the time of the analysis will be censored at the date of last follow-up.
secondary resectability of primary tumor or metastases in patients with DCR	up to 12 years
Tolerance	up to 12 years	graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] criteria v4.03
disease control rate	up to 12 years
Objective Response Rate	up to 12 years	Evaluated by RECIST criteria version 1.1

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besançon, Franche-Comté, France