Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer
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 treatment planning was used instead of CT-based treatment planning alone.
Patients eligible for the study will undergo definitive radiotherapy with or without
concomitant chemotherapy with planning-CT based target volumes, either or not followed by
surgery.
A planning-PET/CT will be made for research purposes only, and will be blinded for the
treating physicians. This planning-PET/CT will not be used for actual treatment planning.
In case of neoadjuvant chemoradiation the response on this therapy will be analysed at
pathologic evaluation of the esophageal specimen.
Routine follow up will be carried out every 6 months, using CT. In case of no locoregional
recurrence and/or metastases, patients will be followed up to 18 months for study
evaluation.
In case of distant metastases, patients will be censored if locoregional recurrence is
excluded. When indicated, palliative treatment will be given.
In case of (suspicion of) locoregional recurrence, PET/CT-based recurrence analysis should
be carried out with comparison and co-registration of CT-based and PET/CT-based target
volumes.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Preventable locoregional recurrence by the use of PET/CT-based treatment planning, instead of CT-based
Proportion of patients with a locoregional recurrence, observed at 6, 12 or 18 months after treatment, can the recurrence be considered as possibly preventable if PET/CT-based treatment planning was used instead of CT-based treatment planning alone (located outside the CT-based CTV, but inside the PET/CT-based CTV)
18 months
No
Johannes A Langendijk, PhD, MD
Principal Investigator
University Medical Center Groningen, Department of Radiation Oncology
Netherlands: Medical Ethics Review Committee (METC)
RESPECT
NCT01836913
May 2009
December 2013
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