Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer (SFP OES)

February 26, 2024 updated by: University Medical Center Groningen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • Recruiting
        • University Medical Center Groningen
        • Contact:
        • Principal Investigator:
          • CT Muijs, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with esophageal cancer receiving a radiotherapy dose > 40 Gy

Description

Inclusion Criteria:

  • Patients with esophageal cancer
  • Patients receiving a radiotherapy dose > 40 Gy

Exclusion Criteria:

  • Failure to comply with any of the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute toxicity
Time Frame: Highest during and within 2 weeks after last day of radiation therapy
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
Highest within one year after last day of radiation therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: At 1,2,3,4 and 5 years after first day of radiation therapy
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
At 1,2,3,4 and 5 years after first day of radiation therapy

Other Outcome Measures

Outcome Measure
Time Frame
Patient-rated symptoms and Quality-of-Life
Time Frame: Before first day of radiation therapy and at 3,6,12,24,36,48,60 months after first day of radiation therapy
Before first day of radiation therapy and at 3,6,12,24,36,48,60 months after first day of radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

May 22, 2015

First Posted (Estimated)

May 27, 2015

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFP OES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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