NCT07632079RecruitingPhase 2
Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer
HYpofractionated Definitive chemoRadiotherapy for Oesophageal Cancer (HYROC): a Multicenter Phase II Feasibility Study
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 28 Apr 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07632079
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 28 Apr 2026 to the primary completion date, Apr 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior thoracic or upper abdominal radiotherapy that would preclude safe delivery of the planned radiotherapy dose.
- Prior chemotherapy for oesophageal or gastric cancer.
Other illness
- Active uncontrolled infection.
- Clinically significant comorbidities that would preclude safe administration of CRT (e.g. severe pulmonary, cardiac, or hepatic impairment).
- 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.
Other
- 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.
- Presence of an oesophageal stent.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Gelre Ziekenhuizen Coordinator of this site? Confirm its status | Apeldoorn | Netherlands | Not yet recruiting |
| Radiotherapiegroep Coordinator of this site? Confirm its status | Apeldoorn | Netherlands | Not yet recruiting |
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Coordinator of this site? Confirm its status | Heerlen | Netherlands | Not yet recruiting |
| Maastro Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| Radboud UMC Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.