OncoMatch/Clinical Trials/NCT04460352
Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer
Is NCT04460352 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Carboplatin, paclitaxel and Carboplatin, paclitaxel for esophageal squamous cell carcinoma.
Treatment: Carboplatin, paclitaxel · Carboplatin, paclitaxel · Cisplatin, paclitaxel · Oxaliplatin, calcium folinate, 5-fluorouracil — NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage CT1 N+ M0, CT2-4A ANY N M0 (AJCC TNM 8th edition)
Excluded: Stage CT4B
locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of of the AJCC TNM classification
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields
Prior or concomitant treatment with radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields
Lab requirements
Kidney function
Adequate organ function. Impaired renal status that compromises eligibility for multimodality treatment is excluded.
Liver function
Adequate organ function. Impaired hepatic status that compromises eligibility for multimodality treatment is excluded.
Cardiac function
Adequate organ function. Impaired cardiac status that compromises eligibility for multimodality treatment is excluded.
Adequate organ function. Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04460352 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields disqualifies patients from enrollment.
What disease stage is eligible?
Stage CT1 N+ M0 or CT2-4A ANY N M0 is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages