Hypofractionated definitive chemoradiotherapy for locally advanced esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial investigates hypofractionated definitive chemoradiotherapy for locally advanced esophageal or GEJ cancer. Participants receive 20 fractions of 2.4 Gy with six cycles of carboplatin and paclitaxel over four weeks, aiming to determine feasibility and safety, including the risk of radiation-induced lymphopenia. The standard follow-up is aligned with current best practice. Eligibility includes adults with specific tumor locations and stages suitable for definitive curative CRT, with adequate organ function and no distant metastases. The study is sponsored by AMC-UvA with collaboration from UMCG and is conducted across Dutch institutions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Clinical stage cT1N1-3M0 or cT2-4aN0-3M0, using the Tumour-Node-Metastasis classification system (TNM, 8th edition), deemed suitable for definitive CRT with curative intent.
* No evidence of distant metastases (M0), as confirmed by standard staging procedures including Fluorine-18 Fluorodeoxyglucose (18F-FDG) PET/CT.
* World Health Organization (WHO) performance status 0-2.
* Adequate hematologic, renal, and hepatic function:

  * Platelet count ≥100 × 10⁹/L
  * Absolute neutrophil count ≥1.5 × 10⁹/L
  * Glomerular filtration rate ≥50 mL/min
  * Total bilirubin ≤1.5 × upper normal limit
* Written informed consent obtained before any study-specific procedures.
* Able to comply with study procedures and scheduled follow-up.

Exclusion Criteria:

* 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.
* Prior chemotherapy for oesophageal or gastric cancer.
* Presence of an oesophageal stent.
* Active uncontrolled infection.
* Clinically significant comorbidities that would preclude safe administration of CRT (e.g. severe pulmonary, cardiac, or hepatic impairment).
* Pregnancy or breastfeeding.
* Known hypersensitivity to paclitaxel, carboplatin, or any of their excipients.
* History of malignancies, with the exception of basal cell carcinoma of the skin, ductal carcinoma in situ of breast, cervical intraepithelial neoplasia of uterine cervix, or other malignancies that do not interfere with the prognosis of oesophageal cancer.

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Umcg
  Groningen, Netherlands Recruiting
• Gelre Ziekenhuizen
  Apeldoorn, Netherlands Not yet recruiting
• Radiotherapiegroep
  Apeldoorn, Netherlands Not yet recruiting
• Zuyderland Medisch Centrum
  Heerlen, Netherlands Not yet recruiting
• Maastro
  Maastricht, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Peter S.N. van Rossum — Amsterdam University Medical Center
• Study coordinator: Iris Agterberg
• Email: i.agterberg@amsterdamumc.nl
• Phone: +31 204441571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.