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Clinical Trials/EUCTR2020-000149-15-SE
EUCTR2020-000149-15-SE
Active, not recruiting
Phase 1

Eoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (NEEDS Trial). - NEEDS

Karolinska University Hospital0 sites1,020 target enrollmentFebruary 3, 2020
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ConditionsResectable locally advanced squamous cell carcinoma (SCC) of the esophagusMedDRA version: 21.1Level: LLTClassification code 10025899Term: Malignant neoplasm of esophagusSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10025901Term: Malignant neoplasm of esophagus, unspecifiedSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus
Sponsor
Karolinska University Hospital
Enrollment
1020
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 3, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Histopathologically confirmed SCC 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
  • •Age \= 18 years and \= 80 years.
  • •Performance status ECOG 0\-1\.
  • •Adequate organ function
  • •Women of childbearing potential 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
  • •Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment
  • •Written informed consent
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •Distant metastases
  • •Primary tumor not resectable without laryngectomy.
  • •Impaired renal, hepatic, cardiac, pulmonary or endocrine status
  • •Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.
  • •Subjects with previous malignancies
  • •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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
Eoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (The NEEDS Trial)Resectable locally advanced squamous cell carcinoma (SCC) of the esophagusTherapeutic area: Diseases [C] - Neoplasms [C04]
CTIS2022-500966-82-00Karolinska University Hospital1,010
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Combined chemotherapy and radiotherapy followed by planned surgery compared to combined chemotherapy and radiotherapy with surgery only when really needed, for patients with cancer in the esophagus.Resectable locally advanced squamous cell carcinoma (SCC) of the esophagusMedDRA version: 21.1Level: LLTClassification code 10025899Term: Malignant neoplasm of esophagusSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10025901Term: Malignant neoplasm of esophagus, unspecifiedSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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