Esophageal NeoplasmsPhase 2SEEDNCT02177552

Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

A Phase 2 study testing Carboplatin, Docetaxel and Capecitabine in people with Esophageal Neoplasms and Stomach Neoplasms, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Esophageal Neoplasms, Stomach Neoplasms
What is being tested?: Carboplatin, Docetaxel and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 1 siteDenmark
Study dates: Jun 2014to Nov 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Finsen Center, Rigshospitalet
Copenhagen, 2100

Other trials in Denmark

About this study

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.

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.

Conditions: Esophageal Neoplasms, Stomach Neoplasms
Being tested: Carboplatin, Docetaxel, Capecitabine, Epirubicin, Oxaliplatin
Keywords: Esophageal cancer, Gastric cancer
Medical subject headings: Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02177552
Study group	Role	What they receive
Experimental chemotherapy	Experimental	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. Receives: Drug: Carboplatin; Drug: Docetaxel; Drug: Capecitabine
Standard chemotherapy	Other	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 Receives: Drug: Capecitabine; Drug: Epirubicin; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of participants alive one year after randomisation
Measured: Three and a half years

Secondary outcomes (6)

Time to progression or death due to any cause
Measured: Three and a half years
Number of participants with grade 3 and 4 toxicities caused by treatments
Measured: Day 1 of every cycle and 30 days after completion of treatment
Time until death due to any cause
Measured: Three and a half years
Changes in quality-of-life
Measured: Three and a half years
The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced
Measured: Five years
Registration of further lines of therapy
Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Nov 2019

First posted27 Jun 2014 (estimated)
Study startJun 2014
Primary completionAug 2019 (estimated)
Study completionNov 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 98 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02177552
Sponsor's protocol ID: 01052014
Other IDs: 2014-000127-24, 2014
Acronym: SEED
Status last verified: Feb 2019
First submitted: 18 Jun 2014
Last updated: 15 Feb 2019
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 34086514

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Esophageal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02177552
Acronym / sponsor ID: SEED / 01052014
Conditions: Esophageal Neoplasms, Stomach Neoplasms
Keywords: Esophageal cancer, Gastric cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 98 participants (estimated)
Lead sponsor: Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
Study start: Jun 2014
Primary completion: Aug 2019 (estimated)
Study completion: Nov 2019 (estimated)
First posted: 27 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental chemotherapy	Experimental	Drug: Carboplatin, Drug: Docetaxel, Drug: CapecitabineIntravenous 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.
Standard chemotherapy	Other	Drug: Capecitabine, Drug: Epirubicin, Drug: OxaliplatinIntravenous 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

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carboplatin	Drug	Experimental chemotherapy
Docetaxel	Drug	Experimental chemotherapy
Capecitabine	Drug	Experimental chemotherapy, Standard chemotherapy
Epirubicin	Drug	Standard chemotherapy
Oxaliplatin	Drug	Standard chemotherapy

Primary outcome

The proportion of participants alive one year after randomisation
Time frame: Three and a half years

6 secondary outcomes

Time to progression or death due to any cause
Time frame: Three and a half years
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
Time until death due to any cause
Time frame: Three and a half years
Changes in quality-of-life
Time frame: Three and a half years
The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced
Time frame: Five years
Registration of further lines of therapy
Time frame: Five years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Derived from this study: PubMed 34086514Petersen 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.

Related trials for Esophageal Neoplasms

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter C Petersen, MD principal investigator

Finsen Center, Rigshospitalet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Docetaxel and Capecitabine in people with Esophageal Neoplasms and Stomach Neoplasms, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of participants alive one year after randomisation (time frame: Three and a half years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02177552, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.