Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

NCT ID: NCT02177552

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-11-30

Brief Summary

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The main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.

Detailed Description

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Conditions

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Esophageal Neoplasms Stomach Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental chemotherapy

Intravenous carboplatin (C) AUC5 day 1 plus intravenous docetaxel (T) 60 mg/m2 day 1 plus oral capecitabine (X) 1000 mg/m2 twice daily from day 1-14, every 4 weeks.

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

Standard chemotherapy

Intravenous epirubicin (E) 50 mg/m2 day 1 plus intravenous oxaliplatin (O) 130 mg/m2 day 1 plus oral capecitabine (X) 625 mg/m2 twice daily continuously, every 3 weeks

Group Type OTHER

Capecitabine

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Interventions

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Carboplatin

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

Epirubicin

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach
* Men or women less than 80 years of age
* Performance status 0 or 1
* Life expectancy \>12 weeks
* Adequate organ-function
* Written informed consent

Exclusion Criteria

* Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months
* Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach
* Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry
* Prior cumulative dose of \>300 mg/m2 of epirubicin
* Grade ≥ 2 side-effects from previous chemotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Peter Clausager Petersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter C Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

Finsen Center, Rigshospitalet

Locations

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Finsen Center, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Petersen PC, Petersen LN, Vogelius I, Bjerregaard JK, Baeksgaard L. A randomized phase 2 trial of first-line docetaxel, carboplatin, capecitabine (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric adenocarcinoma. Acta Oncol. 2021 Jul;60(7):948-953. doi: 10.1080/0284186X.2021.1928281. Epub 2021 Jun 4.

Reference Type DERIVED
PMID: 34086514 (View on PubMed)

Other Identifiers

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2014-000127-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

01052014

Identifier Type: -

Identifier Source: org_study_id

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