Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
The goal of this clinical trial is to learn if hypofractionation of definitive chemoradiotherapy can treat patients with locally advanced esophageal cancer. The main question it aims to answer is if this treatment is feasible and safe. We also want to investigate the toxicity, in particular the radiation-induced lymphopenia.
Normally, definitive chemoradiotherapy for patients with locally advanced esophageal cancer consist of 28 fractions of 1.8 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 5.5 weeks. In this study, participants will receive 20 fractions of 2.4 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 4 weeks. The follow-up will be conform standard-of-care.
Eligibility criteria
Qualifiers
Age ≥18 years.
Histologically confirmed oesophageal or GOJ carcinoma (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma or undifferentiated carcinoma).
An oesophageal tumour location can involve the proximal, middle and/or distal third of the oesophagus.
If the tumour extends below the GOJ into the cardia, the bulk of the tumour must involve the oesophagus or GOJ (i.e. Siewert type I or II). The tumour should not extend more than 5 cm into the stomach.
Disqualifiers
High grade dysplasia without histological evidence of invasive carcinoma.
Presence of distant metastases (M1).
Patients with pathological lymph nodes at both supraclavicular and celiac trunk level.
Prior thoracic or upper abdominal radiotherapy that would preclude safe delivery of the planned radiotherapy dose.
Trial design
Treatments tested in this trial
- Hypofractionation
- carboplatin + paclitaxel (CP)
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
University Medical Center Groningen
Collaborator
Source ClinicalTrials.gov