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

NCT02454790 | Recruiting

• 1 other identifier: SFP OES
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Keywords

Acute toxicity; Late toxicity; Prediction models

Outcome Measures

Primary Outcomes (2)

• Acute toxicity

  Highest during and within 2 weeks after last day of radiation therapy

• Late toxicity

  Highest within one year after last day of radiation therapy

Secondary Outcomes (2)

• Overall survival

  At 1,2,3,4 and 5 years after first day of radiation therapy

• Loco-regional tumor control

  At 1,2,3,4 and 5 years after first day of radiation therapy

Other Outcomes (1)

• 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

Interventions

Radiotherapy RADIATION

Also known as: Chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy; Drug Therapy

Central Study Contacts

CT Muijs, MD PhD

CONTACT

+31503615179; c.t.muijs@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 27, 2015
• Study Start: September 1, 2014
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (1)