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OncoMatch/Clinical Trials/NCT05055648

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

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

Phase 3RecruitingUniversity of AarhusNCT05055648Data as of Jun 2026Location: International · 8 countries

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.

Frequently asked questions

Is NCT05055648 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior thoracic radiation therapy, chemotherapy, surgical resection in the esophageal/gastric region disqualifies patients from enrollment.

What disease stage is eligible?

Stage CT1-4A or CN+ or CM0 is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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