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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Hypofractionation
Radiation20 fractions of 2.4 Gy
carboplatin + paclitaxel (CP)
Drug6 cycles of carboplatin (AUC 2) and paclitaxel (50 mg/m2) given every 4-5 days, 6 cycles in total in 4 weeks.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Hypofractionated definitive chemoradiotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients who complete all 20 fractions of radiotherapy and receive all 6 cycles of concurrent chemotherapy.
Feasibility, defined as ≥50% of patients completing all 20 radiotherapy fractions and all 6 planned chemotherapy cycles.
Time frame
Immediately after the treatment.Secondary outcomes
1
Incidence and severity of grade ≥4 RIL, and absolute lymphocyte count nadirs.
The RIL will be scored according to CTCAE v5.0.
Time frame
Baseline, after first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after the treatment.2
Incidence of grade ≥3 acute toxicity.
The acute toxicity will be scored according to CTCAE v5.0.
Time frame
Baseline, after first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after the treatment.3
Proportion of patients who complete at least 19 of 20 radiotherapy fractions and at least 5 out of 6 planned chemotherapy cycles.
Time frame
Immediately after the treatment.Other outcomes
1
Incidence and severity of treatment-related adverse events.
The adverse events will be scored according to CTCAE v5.0.
Time frame
After first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after treatment, 1 year, 2 years, 3 years, 4 years, 5 years2
Progression Free Survival (PFS) and Overall Survival (OS).
Time frame
1 year, 2 years, 3 years, 4 years, 5 years3
Patient-reported quality of life during and after the treatment.
Assessed using validated questionnaires collected through the POCOP national prospective cohort.
Time frame
Baseline, 3 months after treatment, 1 year, 2 years, 3 years, 4 years, 5 years4
Costs associated with the treatment.
Time frame
3 months after treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
University Medical Center Groningen
Collaborator
Source ClinicalTrials.gov