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RECRUITINGPhase 3INTERVENTIONAL

Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - your organs (liver, kidneys, etc.) are working well enough based on blood tests. - 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 willing to sign a consent form must be given according to ICH/GCP/GDPR and national/local regulations. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

RADIATION

Neoadjuvant radiotherapy (arm A)

1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.

DRUG

Carboplatin, paclitaxel

Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy

PROCEDURE

Esophagectomy

Esophagectomy performed within 8 weeks after termination of chemoradiotherapy

RADIATION

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.

DRUG

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).

DRUG

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.

DRUG

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.

PROCEDURE

Esophagectomy

Esophagectomy only in case of residual or recurrent locoregional cancer.

Locations (12)

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