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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT04920747
Collaborator
(none)
65
Enrollment
1
Location
2
Actual Duration (Months)
33
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
65 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
S group

platin-5FU + trastuzumab
T group

taxanes + platin-5FU + trastuzumab

Drug: Taxane
docetaxel or paclitaxel

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. Objective Response Rate [up to 12 years]

    Evaluated by RECIST criteria version 1.1

  3. disease control rate [up to 12 years]

  4. secondary resectability of primary tumor or metastases in patients with DCR [up to 12 years]

  5. Tolerance [up to 12 years]

    graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] criteria v4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Besancon Besançon Franche-Comté France 25030

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04920747
Other Study ID Numbers:
  • 2021/622
First Posted:
Jun 10, 2021
Last Update Posted:
Jun 10, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Besancon
docetaxel
trastuzumab
Advanced HER2 Positive Gastroesophageal Adenocarcinoma
Additional relevant MeSH terms:
Adenocarcinoma
Taxane

Study Results

No Results Posted as of Jun 10, 2021