Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer
NCT ID: NCT04460352
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
1020 participants
INTERVENTIONAL
2020-11-27
2031-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Study of Neo-adjuvant Chemoradiotherapy for Squamous Cell Esophageal Cancer
NCT02938195
Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer
NCT01463501
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
NCT03731442
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
NCT04027543
Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.
NCT00193882
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control arm (A)
Neoadjuvant chemoradiotherapy followed by esophagectomy.
Radiotherapy: 1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.
Chemotherapy: Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting on the first day of radiotherapy.
Esophagectomy: Within 8 weeks of termination of chemoradiotherapy,
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
Experimental arm (B)
Definitive chemoradiotherapy followed by surveillance, and esophagectomy only in case of residual or recurrent locoregional cancer.
Radiotherapy: 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.
Chemotherapy: Three alternative regimens:
1\. Platin-Taxane Regimen: Carboplatin AUC 2 + Paclitaxel 50mg/m2 on day 1 weekly during the full course of radiotherapy.
2a. Platinum-Fluoropyrimidine Regimen: Cisplatin 75mg/m2 weeks 1 and 5 + 5-fluorouracil 1000 mg/m2/day by continuous infusion weeks 1 and 5.
2b. FOLFOX: Oxaliplatin 85 mg/m2, calcium folinate 200 mg/m2 and 5-fluorouracil 400 mg/m2 weeks 1, 3 and 5 + 5-fluorouracil 800 mg/m2 by continuous infusion weeks 1, 3 and 5.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Leipzig
OTHER
The Swedish Research Council
OTHER_GOV
Karolinska University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Magnus Nilsson
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Magnus Nilsson, MD, PhD
Role: STUDY_CHAIR
Karolinska University Hospital
Florian Lordick, MD, PhD
Role: STUDY_CHAIR
Leipzig University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McGill University Health Centre
Montreal, Quebec, Canada
Cancer Clinical Trials Unit (CCTU) at St. James's Hospital
Dublin, Dublin, Ireland
Oslo universitetssykehus
Oslo, , Norway
Universitetssykehuset Nord-Norge
Tromsø, , Norway
St Olavs Hospital
Trondheim, , Norway
Linköpings universitetssjukhus
Linköping, , Sweden
Skånes universitetssjukhus
Lund, , Sweden
Örebro universitetssjukhus
Örebro, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Norrlands universitetssjukhus
Umeå, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Chang Gung Memorial Hospital
Linkou District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Nilsson M, Olafsdottir H, Alexandersson von Dobeln G, Villegas F, Gagliardi G, Hellstrom M, Wang QL, Johansson H, Gebski V, Hedberg J, Klevebro F, Markar S, Smyth E, Lagergren P, Al-Haidari G, Rekstad LC, Aahlin EK, Wallner B, Edholm D, Johansson J, Szabo E, Reynolds JV, Pramesh CS, Mummudi N, Joshi A, Ferri L, Wong RK, O'Callaghan C, Lukovic J, Chan KK, Leong T, Barbour A, Smithers M, Li Y, Kang X, Kong FM, Chao YK, Crosby T, Bruns C, van Laarhoven H, van Berge Henegouwen M, van Hillegersberg R, Rosati R, Piessen G, de Manzoni G, Lordick F. Neoadjuvant Chemoradiotherapy and Surgery for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed: The Study Protocol for the Randomized Controlled NEEDS Trial. Front Oncol. 2022 Jul 13;12:917961. doi: 10.3389/fonc.2022.917961. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEEDS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.