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

NCT04920747 | Completed

• 1 other identifier: 2021/622
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Gastric Cancer; Metastatic Cancer; Docetaxel; Trastuzumab

Keywords

docetaxel; trastuzumab; Advanced HER2 Positive Gastroesophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival

  up to 12 years

• Objective Response Rate

  up to 12 years

• disease control rate

  up to 12 years

• secondary resectability of primary tumor or metastases in patients with DCR

  up to 12 years

• Tolerance

  up to 12 years

Study Arms (2)

S group

platin-5FU + trastuzumab

T group

taxanes + platin-5FU + trastuzumab

Drug: Taxane

Interventions

Taxane DRUG

docetaxel or paclitaxel

T group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• previous chemotherapy by taxane for metastatic disease,
• previous anti-HER2 therapy.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besancon

Besançon, Franche-Comté, 25030, France

Location

Related Publications (1)

• 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.

  PMID: 35340264 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

taxane

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: April 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)