Locally advanced oesophageal cancer
Conditions
Interventions
In the study treatment, patients will receive 20 fractions of radiotherapy at 2.4 Gy each (total dose 48 Gy), combined with 6 cycles of carboplatin/paclitaxel chemotherapy, all delivered in 4 weeks. T
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age =18 years.Histologically confirmed oesophageal or gastro-oesophageal junction carcinoma (adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma; Siewert type I–II).Clinical stage cT1N1-3M0 or cT2-4aN0-3M0, without distant metastases, suitable for definitive chemoradiotherapy with curative intent.WHO performance status 0–2.Adequate organ function.Written informed consent.
Exclusion criteria
Exclusion criteria: Presence of distant metastases (M1).Pathological lymph nodes at both supraclavicular and truncus coeliacus level.Prior thoracic or upper abdominal radiotherapy or chemotherapy for oesophageal/gastric cancer.Presence of an oesophageal stent.Active uncontrolled infection or significant comorbidities precluding safe CRT.Pregnancy or breastfeeding.Hypersensitivity to paclitaxel or carboplatin.History of other malignancies interfering with prognosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of the study is to test whether this shorter treatment is feasible and safe. Feasibility means that at least 50% of patients are able to complete all 20 radiotherapy sessions and all 6 chemotherapy cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the proportion of patients completing at least 19 of the 20 radiotherapy sessions and at least 5 of the 6 chemotherapy cycles, as well as the incidence and severity of side effects and the degree of white blood cell loss. Exploratory endpoints include effects on survival, quality of life, and healthcare costs. | — |
Countries
Netherlands
Contacts
Public ContactI Agterberg
Amsterdam UMC
Outcome results
None listed