Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer

ClinicalTrials.gov ID

NCT07632079

Lead Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

60Estimated

Last Update Posted

Jun 8, 2026Actual

Start Date

Apr 28, 2026Actual

Primary Completion Date

Apr 2028Estimated

Completion Date

Jul 2028Estimated

Official Title

HYpofractionated Definitive chemoRadiotherapy for Oesophageal Cancer (HYROC): a Multicenter Phase II Feasibility Study

Brief Summary

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.

• Locally Advanced Esophageal or GE Junction Cancer

• Hypofractionation
• carboplatin + paclitaxel (CP)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

Collaborators

University Medical Center GroningenOTHER

k.eechoute@gelre.nl+31 88 105 3300

p.jeene@radiotherapiegroep.nl+31 88 779 0000

c.t.muijs@umcg.nl+31 50 361 6161

f.warmerdam@zuyderland.nl+31 88 459 7777

maaike.berbee@maastro.nl+31 88 445 5600

Heidi.Rutten@radboudumc.nl+31 24-361 11 1

• A Study Involving Neoadjuvant Chemoradiotherapy with Hypofractionated Radiotherapy in Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma

  NCT05370144

  RecruitingInterventionalNot ApplicableUpdated Nov 18, 2024
• Hypofractionated vs. Conventional Chemoradiotherapy After Induction Chemo-immunotherapy for Unresectable Esophageal Squamous Cell Carcinoma

  NCT06912074

  RecruitingInterventionalPhase 2Updated Nov 17, 2025
• A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer

  NCT01843829

  Unknown statusInterventionalPhase 2Updated Mar 24, 2014
• Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus

  NCT01348217

  CompletedInterventionalPhase 2Phase 3Updated Jan 27, 2020
• Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation

  NCT02741856

  Unknown statusInterventionalPhase 2Phase 3Updated Oct 25, 2018
• Hypofractionated Chemoradiotherapy for Cervical Cancer

  NCT07709650

  RecruitingInterventionalPhase 3Updated Aug 24, 2026