- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04920747
Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients (TandHER)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Franche-Comté
-
Besançon, Franche-Comté, France, 25030
- CHU Besançon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
S group
platin-5FU + trastuzumab
|
|
T group
taxanes + platin-5FU + trastuzumab
|
docetaxel or paclitaxel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 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
|
up to 12 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 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.
|
up to 12 years
|
Objective Response Rate
Time Frame: up to 12 years
|
Evaluated by RECIST criteria version 1.1
|
up to 12 years
|
disease control rate
Time Frame: up to 12 years
|
up to 12 years
|
|
secondary resectability of primary tumor or metastases in patients with DCR
Time Frame: up to 12 years
|
up to 12 years
|
|
Tolerance
Time Frame: up to 12 years
|
graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] criteria v4.03
|
up to 12 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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