Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer (RESPECT)
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|ClinicalTrials.gov Identifier: NCT01836913|
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : March 23, 2016
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||90 participants|
|Official Title:||Value of PET-CT in Radiation Treatment Planning for Patients With Esophageal Cancer|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2014|
Radiotherapy for esophageal cancer
Patients with histology proven esophageal cancer who are planned for high dose radiotherapy with or without chemotherapy with or without surgery.
- Preventable locoregional recurrence by the use of PET/CT-based treatment planning, instead of CT-based [ Time Frame: 18 months ]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)
- Differences in GTV, CTV and PTV for CT-based and PET/CT-based treatment planning [ Time Frame: 6 months ]Differences in GTV (gross target volume), CTV and PTV (planning target volume) for CT-based and PET/CT-based treatment planning
- Differences in dose distribution to OAR for CT and PET/CT-based treatment plans [ Time Frame: 6 months ]Dose distribution in critical organs, including lung (mean lung dose, V20), heart (V30) and esophagus and calculation of NTCP values (Normal Tissue Complication Probability) comparing 3D-CRT and IMRT with and without PET/CT-based treatment planning
- Percentage of patients who develop distant metastases after treatment [ Time Frame: 18 months ]Percentage of patients who develop distant metastases after treatment
- Cost-effectivity analyses [ Time Frame: 24 months ]The costs of radiotherapy planning and treatment (surgical and/or chemoradiation), complications and recurrence-related treatment or the prevention thereof.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836913
|Deventer, Overijssel, Netherlands|
|Medisch spectrum twente|
|Enschede, Overijssel, Netherlands|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700RB|
|Principal Investigator:||Johannes A Langendijk, PhD, MD||University Medical Center Groningen, Department of Radiation Oncology|
|Principal Investigator:||John Th Plukker, PhD, MD||University Medical Center Groningen, Department of Surgical Oncology|