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Recruiting NCT07632079

Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer

Phase II Interventional Locally Advanced Esophageal or GE Junction Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypofractionation, carboplatin + paclitaxel (CP).
Who it may be relevant to
Registry conditions: Locally Advanced Esophageal or GE Junction Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Hypofractionation
    20 fractions of 2.4 Gy
  • Drug carboplatin + paclitaxel (CP)
    6 cycles of carboplatin (AUC 2) and paclitaxel (50 mg/m2) given every 4-5 days, 6 cycles in total in 4 weeks.

Primary outcome measures

  • Proportion of patients who complete all 20 fractions of radiotherapy and receive all 6 cycles of concurrent chemotherapy. [Time frame: Immediately after the treatment.]
Secondary outcome measures (3)
  • Incidence and severity of grade ≥4 RIL, and absolute lymphocyte count nadirs. [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. [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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 7 centers
  • Amsterdam UMC — Amsterdam
  • Gelre Ziekenhuizen — Apeldoorn
  • Radiotherapiegroep — Apeldoorn
  • UMCG — Groningen
  • Zuyderland Medisch Centrum — Heerlen
  • Maastro — Maastricht
  • Radboud UMC — Nijmegen

Identifiers

NCT: NCT07632079 · NL-010499

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗