Comparing two treatment approaches for esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial aims to compare the outcomes of neoadjuvant chemoradiotherapy followed by surgery against definitive chemoradiotherapy with surveillance and surgery only when necessary in patients with resectable locally advanced esophageal squamous cell carcinoma. The study is designed as a pragmatic, open-label, randomized, controlled trial with a focus on overall survival, health-related quality of life, and eating restrictions one year after randomization. By evaluating these two treatment strategies, the trial seeks to provide guidance for future clinical practice in managing this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of of the AJCC TNM classification.
* Technically resectable disease according to the local multidisciplinary team conference (MDT)/tumor board.
* Performance status ECOG 0-1.
* Adequate organ function.
* Women of childbearing potential (WOCBP\*) must have a negative serum or urine pregnancy test.
* Patients of childbearing/reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least five months after the last study treatment.
* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
* Before patient registration/randomization, written informed consent must be given according to ICH/GCP/GDPR and national/local regulations.

Exclusion Criteria:

* M1 according to current (8th) version of of the AJCC TNM classification.
* cT4b according to current (8th) version of of the AJCC TNM classification.
* Primary tumor not resectable without laryngectomy.
* Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy.
* Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.
* Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.
* Prior or concomitant treatment with radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields.
* Known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens.
* Inability to fully understand and digest study patient information or to comply with study instructions due to language difficulty or cognitive failure such as dementia or severe psychiatric disorder.

(Criteria slightly shortened)

Where it's running

• McGill University Health Centre
  Montreal, Quebec, Canada Recruiting
• Cancer Clinical Trials Unit (CCTU) at St. James's Hospital
  Dublin, Dublin, Ireland Recruiting
• Oslo universitetssykehus
  Oslo, Norway Recruiting
• Universitetssykehuset Nord-Norge
  Tromsø, Norway Recruiting
• St Olavs Hospital
  Trondheim, Norway Recruiting
• Linköpings universitetssjukhus
  Linköping, Sweden Recruiting

Study contacts

• Study coordinator: Magnus Nilsson, MD, PhD
• Email: magnus.nilsson@ki.se
• Phone: +46-707-375186

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

  This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07858630

• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

  This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.

  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• SKB500 combinations for esophageal squamous cell carcinoma

  This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.

  Recruiting at 24 sites Phase 2 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Changchun and 23 other locations · NCT07700667

• Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

  This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.

  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT07699185

• Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma

  In people with locally advanced ESCC who respond to neoadjuvant immunochemotherapy, this study tests whether organ preservation with treatment other than surgery can be as effective as radical esophagectomy.

  Recruiting Phase 3 Henan Cancer Hospital · Zhengzhou, Henan · NCT07629817

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.