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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02454790
Other study ID # SFP OES
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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