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

Esophageal Cancer Clinical Trial

— SFP OES  

Official title:

Standard Follow-up Program (SFP) for Esophageal Cancer Patients Treated With Radiotherapy or Chemoradiation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02454790
• Other study ID #: SFP OES
• Status: Recruiting
• Start date: September 2014
• Est. completion date: January 2030

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: CT Muijs, MD PhD
• Phone: +31503615179
• Email: c.t.muijs[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with esophageal cancer

• Patients receiving a radiotherapy dose > 40 Gy

Exclusion Criteria:

• Failure to comply with any of the inclusion criteria

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-rated symptoms and Quality-of-Life		Before first day of radiation therapy and at 3,6,12,24,36,48,60 months after first day of radiation therapy
Primary	Acute toxicity		Highest during and within 2 weeks after last day of radiation therapy
Primary	Late toxicity		Highest within one year after last day of radiation therapy
Secondary	Overall survival		At 1,2,3,4 and 5 years after first day of radiation therapy
Secondary	Loco-regional tumor control		At 1,2,3,4 and 5 years after first day of radiation therapy