Clinical trial NCT04920747: Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients
Official title: Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2-positive Gastric Cancer
Metastatic Cancer
Docetaxel
Trastuzumab
Keywords: docetaxel
trastuzumab
Advanced HER2 Positive Gastroesophageal Adenocarcinoma
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated between January 2009 and Mars 2021 were included, in 7 centers in Franche-Comte region in France.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival
timeFrame: up to 12 years
Secondary outcomes:
measure: Overall survival
timeFrame: up to 12 years
measure: Objective Response Rate
timeFrame: up to 12 years
measure: disease control rate
timeFrame: up to 12 years
measure: secondary resectability of primary tumor or metastases in patients with DCR
timeFrame: up to 12 years
measure: Tolerance
timeFrame: up to 12 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besancon
state: Franche-Comté
Study officials:
References:
citation: 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.