Evaluating lymph node metastases in esophageal cancer after surgery
Distribution of Lymph Node Metastases in Esophageal Carcinoma
This study is trying to understand how lymph node cancer spreads in people with esophageal cancer after surgery to see if it can help predict their recovery and survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 19 sites (Houston, Texas and 18 other locations) |
| Trial ID | NCT03222895 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the distribution of lymph node metastases in patients with esophageal carcinoma following transthoracic esophagectomy with at least a 2-field lymphadenectomy. It will include patients with resectable esophageal or gastro-esophageal junction carcinoma from multiple centers across 18 countries over a period of approximately 7 years. The study will also evaluate the accuracy of preoperative diagnostics and the prognostic value of different lymph node stations, as well as overall and disease-free survival rates.
Who should consider this trial
Good fit: Ideal candidates are patients with resectable primary squamous cell or adenocarcinoma of the esophagus or esophago-gastric junction who are in adequate physical condition for surgery.
Not a fit: Patients with previous thoracic or abdominal surgeries that disrupt lymph drainage or those with in situ carcinoma or high-grade dysplasia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical strategies and outcomes for patients with esophageal cancer by providing insights into lymph node metastasis patterns.
How similar studies have performed: While the study's specific focus on lymph node distribution in a large cohort is novel, similar studies have shown the importance of lymph node status in esophageal cancer prognosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary squamous cell or adenocarcinoma of the esophagus or esophago-gastric junction * Surgically resectable (cT1-4a, N0-3, M0) * Adequate physical condition to undergo transthoracic surgery (ASA 1-3) * Transthoracic esophagectomy Exclusion Criteria: * Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach * Patients with in situ carcinoma or high grade dysplasia
Where this trial is running
Houston, Texas and 18 other locations
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Instituto Nacional de Câncer — Rio de Janeiro, Brazil (Recruiting)
- University of Toronto — Toronto, Canada (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Yangpu, China (Recruiting)
- Hospital District of Helsinki and Uusimaa — Helsinki, Finland (Recruiting)
- University Medical Center of the Johannes Gutenberg University — Mainz, Germany (Recruiting)
- University of Athens, School of Medicine — Athens, Greece (Recruiting)
- University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
- Tata Memorial Centre — Mumbai, India (Recruiting)
- IRCCS Policlinico San Donato — Milan, Italy (Recruiting)
- Ospedale San Raffaele — Milan, Italy (Recruiting)
- University of Verona — Verona, Italy (Recruiting)
- Uonuma Institute and Niigata University — Niigata, Japan (Recruiting)
- Keio University School of Medicine — Tokyo, Japan (Recruiting)
- The Cancer Institute Hospital of JFCR — Tokyo, Japan (Recruiting)
- Ziekenhuisgroep Twente, Almelo & Hengelo — Almelo, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Hospital Universitario del Mar — Barcelona, Spain (Recruiting)
- Karolinska Institutet — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Mark I van Berge Henegouwen, MD, PHD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Suzanne S Gisbertz, MD, PhD
- Email: s.s.gisbertz@amc.nl
- Phone: +31205669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.