Esophageal CancerEUFURONCT02209415
EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer
A study testing standard follow-up and PET/CT and EUS in people with Esophageal Cancer and Stomach Cancer, run by Michael Bau Mortensen at 1 site in Denmark.
Trial summary
Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic. This is because the methods and the consequence of following these patients is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Stomach Cancer, Pancreatic Cancer
- What is being tested?
- standard follow-up and PET/CT and EUS
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Aug 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Surgical Ultrasound, Department of upper surgical gastroenterology
Odense, Region Syddanmark, 5000
About this study
Official title: Endoscopic Ultrasound (EUS) and PET-CT Based Follow-up of Patients Radically Resected for Cancer of the Oesophagus, Stomach or Pancreas.
Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic.
This is because the methods and the consequence of following these patients is unknown.
Therefore the investigators will randomize these patients in to two groups:
- One group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department.
- The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.
- Conditions
- Esophageal Cancer, Stomach Cancer, Pancreatic Cancer
- Being tested
- standard follow-up, PET/CT and EUS
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard follow-upBehavioural
Outpatient clinic visits
PET/CT and EUSProcedure or surgery
PET/CT and EUS
| Study group | Role | What they receive |
|---|---|---|
| Standard outpatient follow-up | Active comparator | Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery Receives: Behavioral: standard follow-up |
| Intervention PET/CT and EUS | Experimental | PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery Receives: Procedure: PET/CT and EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients eligible for treatment
Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startApr 2011
- Primary completionJan 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Bau Mortensen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor-investigator, Michael Bau Mortensen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209415
- Sponsor's protocol ID
- 2011-41-5702
- Acronym
- EUFURO
- Status last verified
- Aug 2014
- First submitted
- 28 Nov 2011
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bjerring OS, Fristrup CW, Pfeiffer P, Lundell L, Mortensen MB. Phase II randomized clinical trial of endosonography and PET/CT versus clinical assessment only for follow-up after surgery for upper gastrointestinal cancer (EUFURO study). Br J Surg. 2019 Dec;106(13):1761-1768. doi: 10.1002/bjs.11290. Epub 2019 Oct 9.
PubMed 31595970Bjerring OS, Hess S, Fristrup CW, Hoilund-Carlsen PF, Mortensen MB. The impact of endoscopic ultrasound-guided fine-needle aspiration of lymph nodes on subsequent positron emission tomography/computed tomography imaging: a prospective study. Endoscopy. 2019 Feb;51(2):165-168. doi: 10.1055/a-0647-6824. Epub 2018 Jul 23.
PubMed 30036892
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound (EUS) and PET-CT Based Follow-up of Patients Radically Resected for Cancer of the Oesophagus, Stomach or Pancreas.
- ClinicalTrials.gov ID
- NCT02209415
- Acronym / sponsor ID
- EUFURO / 2011-41-5702
- Conditions
- Esophageal Cancer, Stomach Cancer, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Michael Bau MortensenUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Apr 2011
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 5 Aug 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.
Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic.
This is because the methods and the consequence of following these patients is unknown.
Therefore the investigators will randomize these patients in to two groups:
- One group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department.
- The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard outpatient follow-up | Active comparator | Behavioral: standard follow-upOutpatient clinic visits 3,6,9,12,18 and 24 mths after surgery |
| Intervention PET/CT and EUS | Experimental | Procedure: PET/CT and EUSPET/CT and EUS at 3,6,9,12,18 and 24 months after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| standard follow-upOutpatient clinic visits | Behavioural | Standard outpatient follow-up |
| PET/CT and EUSPET/CT and EUS | Procedure or surgery | Intervention PET/CT and EUS |
Primary outcome
Number of patients eligible for treatment
Time frame: 2 years
Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Derived from this study: PubMed 31595970Bjerring OS, Fristrup CW, Pfeiffer P, Lundell L, Mortensen MB. Phase II randomized clinical trial of endosonography and PET/CT versus clinical assessment only for follow-up after surgery for upper gastrointestinal cancer (EUFURO study). Br J Surg. 2019 Dec;106(13):1761-1768. doi: 10.1002/bjs.11290. Epub 2019 Oct 9.
- Derived from this study: PubMed 30036892Bjerring OS, Hess S, Fristrup CW, Hoilund-Carlsen PF, Mortensen MB. The impact of endoscopic ultrasound-guided fine-needle aspiration of lymph nodes on subsequent positron emission tomography/computed tomography imaging: a prospective study. Endoscopy. 2019 Feb;51(2):165-168. doi: 10.1055/a-0647-6824. Epub 2018 Jul 23.
Related trials for Esophageal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection
Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 4
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Gastrointestinal Cancer, Gastric 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard follow-up and PET/CT and EUS in people with Esophageal Cancer and Stomach Cancer, run by Michael Bau Mortensen 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 1 inclusion and 0 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 5 Aug 2014. 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.
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?
Number of patients eligible for treatment (time frame: 2 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 NCT02209415, which also lists 2 linked publications.
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 5 Aug 2014.