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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
20 fractions of 2.4 Gy
6 cycles of carboplatin (AUC 2) and paclitaxel (50 mg/m2) given every 4-5 days, 6 cycles in total in 4 weeks.
Amsterdam UMC
Amsterdam, Netherlands
RECRUITINGGelre Ziekenhuizen
Apeldoorn, Netherlands
NOT_YET_RECRUITINGRadiotherapiegroep
Apeldoorn, Netherlands
NOT_YET_RECRUITINGUMCG
Groningen, Netherlands
RECRUITINGZuyderland Medisch Centrum
Heerlen, Netherlands
NOT_YET_RECRUITINGMaastro
Maastricht, Netherlands
NOT_YET_RECRUITINGRadboud UMC
Nijmegen, Netherlands
NOT_YET_RECRUITINGProportion 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.
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.
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.
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.
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