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OncoMatch/Clinical Trials/NCT05055648

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

Is NCT05055648 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for esophageal cancer.

Phase 3RecruitingUniversity of AarhusNCT05055648Data as of May 2026

The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage CT1-4A, CN+, CM0 (TNM (8th edition))

Tumor stage according to TNM (8th edition): cT1-4a and/or cN+, cM0

Performance status

WHO 0–2

Prior therapy

Cannot have received: thoracic radiation therapy

Prior thoracic XT or PT

Cannot have received: chemotherapy

Prior ... chemotherapy ... in the esophageal/gastric region

Cannot have received: surgical resection in the esophageal/gastric region

Exception: previous EMR or ESD is allowed

Prior ... surgical resection in the esophageal/gastric region (previous EMR or ESD is allowed)

Lab requirements

Blood counts

hemoglobin > 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 75 x 10^9/L

Kidney function

creatinine ≤ 1.5 x ULN, GFR > 30 ml/min

Liver function

bilirubin ≤ 1.5 x upper limit of normal (ULN), ALAT ≤ 3 x ULN

Adequate laboratory findings: hematological: hemoglobin > 90 g/L, absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), ALAT ≤ 3 x ULN renal: creatinine ≤ 1.5 x ULN, GFR (may be calculated) > 30 ml/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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