A Study of Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Cancer of the Esophagus

• Status: Recruiting
• Trial end date: 2031-12-31
• Target enrollment: 0
• Participant gender: All

Summary

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy with regard to the main secondary endpoint global health related quality of life (HRQOL) one year after randomisation.

The aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Collaborators: The Swedish Research Council; University of Leipzig
• Treatments: Albumin-Bound Paclitaxel; Calcium; Carboplatin; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin; Paclitaxel

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)