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.

Phase 1

• Conditions: Resectable locally advanced squamous cell carcinoma (SCC) of the esophagus; MedDRA version: 21.1Level: LLTClassification code 10025899Term: Malignant neoplasm of esophagusSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10025901Term: Malignant neoplasm of esophagus, unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000149-15-IE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-02
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1020

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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 612

Exclusion Criteria

• Distant metastases
• cT4b
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified