- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01156831
PET-CT Based Radiotherapy in Esophageal Cancer Patients
December 5, 2014 updated by: Maastricht Radiation Oncology
Consequences of Positron-Emission-Tomography/Computed Tomography (PET/CT) Based Radiotherapy Treatment Planning for Clinical Outcome in Esophageal Cancer Patients
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients.
Study Overview
Status
Completed
Conditions
Detailed Description
The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients
Study Type
Observational
Enrollment (Actual)
115
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Heerlen, Netherlands
- Atrium Hospital
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Maastricht, Netherlands
- University Medical Center
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Roermond, Netherlands
- St. Laurentius Hospital
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Sittard, Netherlands
- Maasland Hospital
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Weert, Netherlands
- St. Jansgasthuis
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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
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Primary Care Clinic
Description
Inclusion Criteria:
- Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus
- Local curable disease able to undergo Chemoradiotherapy.
Exclusion Criteria:
- Metastasized disease.
- Previous or concurrent malignancies.
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 |
|---|---|
|
Locoregional control
Time Frame: 2 years and 5 years
|
2 years and 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: 2 years and 5 years
|
2 years and 5 years
|
|
|
Disease Free survival
Time Frame: 2 years and 5 years
|
2 years and 5 years
|
|
|
Tumor regression grade
Time Frame: At the time of surgery
|
Tumor regression grade at time of surgery evaluated by pathologist.
|
At the time of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guido Lammering, MD PhD, Radiation Oncology, Maastro Clinic
- Principal Investigator: Meindert Sosef, MD PhD, Atrium Hospital Heerlen
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
November 1, 2007
Primary Completion (ACTUAL)
May 1, 2011
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
July 2, 2010
First Submitted That Met QC Criteria
July 2, 2010
First Posted (ESTIMATE)
July 5, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
December 8, 2014
Last Update Submitted That Met QC Criteria
December 5, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-18-12/08
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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