Esophageal CancerSFP OESNCT02454790
Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer
An observational study of Esophageal Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Motive: In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Jan 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with esophageal cancer receiving a radiotherapy dose > 40 Gy
Who may be able to join
- Patients with esophageal cancer
- Patients receiving a radiotherapy dose > 40 Gy
Who cannot join
- Failure to comply with any of the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700RB
CT Muijs, MD PhD, +31503615179, c.t.muijs@umcg.nl
CT Muijs, MD PhD
About this study
Official title: Standard Follow-up Program (SFP) for Esophageal Cancer Patients Treated With Radiotherapy or Chemoradiation
Motive:
In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.
Goal:
To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
- Conditions
- Esophageal Cancer
- Being tested
- Radiotherapy
- Keywords
- Acute toxicity, Late toxicity, Prediction models
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called Chemoradiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Measured: Highest during and within 2 weeks after last day of radiation therapy
Late toxicity
Measured: Highest within one year after last day of radiation therapy
Secondary outcomes (2)
Overall survival
Measured: At 1,2,3,4 and 5 years after first day of radiation therapy
Loco-regional tumor control
Measured: At 1,2,3,4 and 5 years after first day of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startSep 2014
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454790
- Sponsor's protocol ID
- SFP OES
- Acronym
- SFP OES
- Status last verified
- Feb 2024
- First submitted
- 22 May 2015
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Follow-up Program (SFP) for Esophageal Cancer Patients Treated With Radiotherapy or Chemoradiation
- ClinicalTrials.gov ID
- NCT02454790
- Acronym / sponsor ID
- SFP OES / SFP OES
- Conditions
- Esophageal Cancer
- Keywords
- Acute toxicity, Late toxicity, Prediction models
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 27 May 2015 (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.
Motive:
In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.
Goal:
To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal cancer receiving a radiotherapy dose > 40 Gy
Key inclusion criteria (2 listed)
- Patients with esophageal cancer
- Patients receiving a radiotherapy dose > 40 Gy
Key exclusion criteria (1 listed)
- Failure to comply with any of the inclusion criteria
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 |
|---|---|---|
| RadiotherapyAlso: Chemoradiation | Radiation | – |
Primary outcome
Acute toxicity
Time frame: Highest during and within 2 weeks after last day of radiation therapy
Late toxicity
Time frame: Highest within one year after last day of radiation therapy
2 secondary outcomes
Overall survival
Time frame: At 1,2,3,4 and 5 years after first day of radiation therapy
Loco-regional tumor control
Time frame: At 1,2,3,4 and 5 years after first day of radiation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Feb 2024. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CT Muijs, MD PhD (+31503615179, c.t.muijs@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: Highest during and within 2 weeks after last day of radiation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.