Neoadjuvant radiotherapy (arm A): 1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.
Carboplatin, paclitaxel: Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy
Esophagectomy: Esophagectomy performed within 8 weeks after termination of chemoradiotherapy
Neoadjuvant radiotherapy (arm B): Two alternative schemes:
1. 1.8 Gy fractions five days per week in 28 fractions to a total dose of 50.4 Gy.
2. 2.0 Gy fractions five days per week in 25 fractions to a total dose of 50 Gy.
Carboplatin, paclitaxel: Carboplatin AUC 2 + Paclitaxel 50mg/m2 on day 1 weekly during the full course of radiotherapy (5 weeks or 6 weeks, depending on the radiotherapy regimen used).
Cisplatin, paclitaxel: Cisplatin 75mg/m2 on the first day of weeks 1 and 5 + 5-fluorouracil 1000 mg/m2/day by continuous infusion on the first four days of weeks 1 and 5.
Oxaliplatin, calcium folinate, 5-fluorouracil: FOLFOX: Oxaliplatin 85 mg/m2, calcium folinate 200 mg/m2 and 5-fluorouracil 400 mg/m2 on the first days of weeks 1, 3 and 5 + 5-fluorouracil 800 mg/m2 by continuous infusion on the first two days of weeks 1, 3 and 5.
Esophagectomy: Esophagectomy only in case of residual or recurrent locoregional cancer.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Overall survival — 3 years after randomisation When 398 events have occurred
Global Health-related quality of life (HRQOL) — 1 year after randomisation European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, version 3.0 (EORTC QLQ-C30). The two items assessing global health and overall quality of life are responded to in seven categories ranging from 1 (very poor) to 7 (excellent).
Eating restrictions — 1 year after randomisation EORTC QLQ-OG25 instrument. This instrument consists of 25 items covering upper gastric symptoms or problems in four categories ranging from 1 (Not at all) to 4 (Very much).
Trial sites (12)
Facility
City
Region
Status
McGill University Health Centre
Montreal
Quebec
Recruiting
Cancer Clinical Trials Unit (CCTU) at St. James's Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
