NCT07632079 Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer
| NCT ID | NCT07632079 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Locally Advanced Esophageal or GE Junction Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-04-28 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Peter S.N. van Rossum
PRINCIPAL INVESTIGATOR
Amsterdam University Medical Center
Frequently Asked Questions
Who can join the NCT07632079 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Esophageal or GE Junction Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07632079 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07632079 currently recruiting?
Yes, NCT07632079 is actively recruiting participants. Contact the research team at i.agterberg@amsterdamumc.nl for enrollment information.
Where is the NCT07632079 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Apeldoorn, Netherlands, Apeldoorn, Netherlands, Groningen, Netherlands and 3 additional locations.
Who is sponsoring the NCT07632079 clinical trial?
NCT07632079 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Peter S.N. van Rossum at Amsterdam University Medical Center. The trial plans to enroll 60 participants.
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