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NEoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (The NEEDS Trial)
EU CTIS ID: 2022-500966-82-00
What this study is testing
To demonstrate that dCRT with salvage esophagectomy as needed, is non-inferior to nCRT followed by surgery, regarding overall survival in patients with operable, locally advanced esophageal squamous cell carcinoma.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histopathologically confirmed squamous cell carcinoma of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0
- Technically resectable disease according to the local multidisciplinary team conference (MDT)/tumor board.
- Performance status ECOG 0-1.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to randomisation.
- Patients of childbearing/reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least six months after the last study treatment.
- Before patient registration/randomisation, written informed consent must be given according to ICH/GCP/GDPR and national/local regulations.
You likely can't join if
- 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 with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.
- 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.
See the full eligibility criteria
- Histopathologically confirmed squamous cell carcinoma of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0
- Technically resectable disease according to the local multidisciplinary team conference (MDT)/tumor board.
- Performance status ECOG 0-1.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to randomisation.
- Patients of childbearing/reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least six months after the last study treatment.
- Before patient registration/randomisation, written informed consent must be given according to ICH/GCP/GDPR and national/local regulations.
- Age ≥ 18 years and ≤ 80 years.
- Adequate organ function
- Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment
- 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 with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.
- 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.
- Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- China
- United Kingdom
- India
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; United Kingdom; India; Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.