Status:
COMPLETED
Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The RESPECT study is intended to prospectively assess the impact of PET/CT on the delineation of target volumes and to estimate the proportion of recurrences that could possibly be prevented by the us...
Detailed Description
This is a prospective cohort study testing the hypothesis that in a proportion of patients, locoregional recurrence, observed at 6, 12 or 18 months after treatment, can be prevented if PET/CT-based tr...
Eligibility Criteria
Inclusion
- Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus or GEJ
- Locally curable disease without distant metastases (M1b is excluded) (TNM clinical classification UICC 7th edition)
- Planned for high dose radiotherapy with or without chemotherapy with or without surgery
- Age ≥ 18 years;
- WHO performance status 0-2
- informed consent must be given according to ICH/EU GCP, and national/local regulations
Exclusion
- previous or concurrent malignancies (except basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder cancer (pTa)) in the past five years
- Previous treatment
- Evidence of serious active infections
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01836913
Start Date
May 1 2009
End Date
April 1 2014
Last Update
March 23 2016
Active Locations (3)
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1
RISO
Deventer, Overijssel, Netherlands
2
Medisch spectrum twente
Enschede, Overijssel, Netherlands
3
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9700RB