AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer

RecruitingPhase 2Ages 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Amsโ€ฆ
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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 โ‰ฅ100 ร— 10โน/L * Absolute neutrophil count โ‰ฅ1.5 ร— 10โน/L * Glomerular filtration rate โ‰ฅ50 mL/min * Total bilirubin โ‰ค1.5 ร— 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.
๐Ÿ’Š

What it tests

  • Hypofractionation
  • carboplatin + paclitaxel (CP)
๐Ÿ“

Where

7 sites
Amsterdam UMC
Amsterdam, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Radiotherapiegroep
Apeldoorn, Netherlands
UMCG
Groningen, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Maastro
Maastricht, Netherlands
Radboud UMC
Nijmegen, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy