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

Metastatic Cancer Clinical Trial

— TandHER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920747
• Other study ID #: 2021/622
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Docetaxel
• HER2-positive Gastric Cancer
• Metastatic Cancer
• Trastuzumab

Intervention

Drug:
• Taxane
docetaxel or paclitaxel

Locations

Country	Name	City	State
France	CHU Besancon	Besançon	Franche-Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	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	up to 12 years
Secondary	Overall survival	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.	up to 12 years
Secondary	Objective Response Rate	Evaluated by RECIST criteria version 1.1	up to 12 years
Secondary	disease control rate		up to 12 years
Secondary	secondary resectability of primary tumor or metastases in patients with DCR		up to 12 years
Secondary	Tolerance	graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] criteria v4.03	up to 12 years