Esophageal cancer Esophageal cancer
Conditions
Interventions
After informed consent and before treatment, patients will be trained in one session to feel safe and comfortable while being non-invasively mechanically ventilated via a face mask with an antibacteri
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age =18 yearsCondition: WHO performance score 0-1 Biopsy-proven carcinoma of the oesophagus or GOJ, stage cT2-4aN0-3M0 or cT1-4aN1-3M0Scheduled for neoadjuvant chemoradiotherapyConsidered fit for surgery (i.e. operable) by an Upper GI surgeonAdequate communication and understanding skills of Dutch languageSigned informed consent (IC)
Exclusion criteria
Exclusion criteria: A history of severe COPD (GOLD IV)A history of pulmonary hypertensionKnown increased intracranial pressureHistory of pneumothorax in the past 5 yearsOesophageal stent in situPatients unable to cooperate or to lie flat on their back for up to 30 minutesPrevious irradiation overlapping with intended new radiotherapy fields
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this phase II study is to investigate the feasibility of combining a standard of care oART approach with experimental NIMV-induced RB during radiotherapy for patients undergoing neoadjuvant CRT for oesophageal or GOJ cancer. Feasibility is defined as finding that =80% of patients complete at least 18 out of 23 fractions using oART with NIMV-induced RB. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include the assessment of patient comfort, treatment toxicity and treatment time. Also, the dosimetric impact of oART with NIMV-induced RB compared to a simulated conventional non-oART non-NIMV approach and an oART non-NIMV approach in the same patients will be evaluated. Other secondary endpoints include quantification of interfraction and intrafraction motion patterns of the target volume, margins and surrounding organs. | — |
Countries
Netherlands
Contacts
Public ContactP.S.N. van Rossum
Amsterdam UMC
Outcome results
None listed