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Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma (SEED)

Primary Purpose

Esophageal Neoplasms, Stomach Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Carboplatin
Docetaxel
Capecitabine
Epirubicin
Oxaliplatin
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Esophageal cancer, Gastric cancer

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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

Key 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

Sites / Locations

  • Finsen Center, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental chemotherapy

Standard chemotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The proportion of participants alive one year after randomisation

Secondary Outcome Measures

Time to progression or death due to any cause
Number of participants with grade 3 and 4 toxicities caused by treatments
Time until death due to any cause
Changes in quality-of-life
The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced
Registration of further lines of therapy

Full Information

First Posted
June 18, 2014
Last Updated
February 13, 2019
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02177552
Brief Title
Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma
Acronym
SEED
Official Title
Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Stomach Neoplasms
Keywords
Esophageal cancer, Gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard chemotherapy
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Primary Outcome Measure Information:
Title
The proportion of participants alive one year after randomisation
Time Frame
Three and a half years
Secondary Outcome Measure Information:
Title
Time to progression or death due to any cause
Time Frame
Three and a half years
Title
Number of participants with grade 3 and 4 toxicities caused by treatments
Time Frame
Day 1 of every cycle and 30 days after completion of treatment
Title
Time until death due to any cause
Time Frame
Three and a half years
Title
Changes in quality-of-life
Time Frame
Three and a half years
Title
The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced
Time Frame
Five years
Title
Registration of further lines of therapy
Time Frame
Five years
Other Pre-specified Outcome Measures:
Title
Analysis of cmet by immunohistochemistry
Description
Analysis of archived tumour tissue (primary biopsy, previous surgical resection specimen if available) and metastatic tumour tissue for consenting subjects.
Time Frame
Three and a half years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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 Key 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Petersen, MD
Organizational Affiliation
Finsen Center, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Finsen Center, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34086514
Citation
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.
Results Reference
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Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

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