Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Лучевая терапия Hypofractionation
  20 fractions of 2.4 Gy
• Препарат 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.

Первичные конечные точки

• Proportion of patients who complete all 20 fractions of radiotherapy and receive all 6 cycles of concurrent chemotherapy. [Срок оценки: Immediately after the treatment.]

Вторичные конечные точки (3)

• Incidence and severity of grade ≥4 RIL, and absolute lymphocyte count nadirs. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Immediately after the treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 7 центров

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

Идентификаторы

NCT: NCT07632079 · NL-010499

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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