Comparing two treatment approaches for esophageal cancer
NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)
This study is testing two different treatment plans for people with advanced esophageal cancer to see which one helps them live longer and feel better after a year.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1020 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 12 sites (Montreal, Quebec and 11 other locations) |
| Trial ID | NCT04460352 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with histopathologically confirmed locally advanced esophageal squamous cell carcinoma who are technically resectable and have a performance status of ECOG 0-1.
Not a fit: Patients with non-resectable disease or those with significant comorbidities that affect treatment compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with esophageal cancer.
How similar studies have performed: Other studies have shown promise with similar approaches in treating esophageal cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montreal, Quebec and 11 other locations
- 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)
- Skånes universitetssjukhus — Lund, Sweden (Recruiting)
- Örebro universitetssjukhus — Örebro, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Norrlands universitetssjukhus — Umeå, Sweden (Recruiting)
- Akademiska sjukhuset — Uppsala, Sweden (Recruiting)
- Chang Gung Memorial Hospital — Linkou District, Taiwan (Recruiting)
Study contacts
- Study coordinator: Magnus Nilsson, MD, PhD
- Email: magnus.nilsson@ki.se
- Phone: +46-707-375186
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.