Double-blinded (treatment group unknown to physician and patient), randomised (treatment group allocated by chance) phase II trial on the efficacy and tolerability of an 8 week treatment with two different doses of budesonide tablets dissolving in the mouth compared to placebo (medication without active substance), for prevention of constrictions of the oesophagus in adult patients after removal of cancer tissue using an endoscopic surgery technique

Phase 1

• Conditions: Prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection; MedDRA version: 25.1Level: LLTClassification code 10030186Term: Oesophageal squamous cell carcinoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10004137Term: Barrett's oesophagusSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-002617-35-DE
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-28
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Signed informed consent;
• Male or female patients, 18 to 85 years of age;
• Estimated life expectancy of at least one year (not applicable in Portugal);
• ECOG Performance Status of = 2 at the randomisation visit (i.e. after the ESD-procedure);
• a) Biopsy proven or endoscopically suspect oesophageal SCC and/or high grade dysplasia in a focal lesion of the squamous epithelium, treated with ESD;
or
b) Biopsy proven or endoscopically suspect BE-HGD or EAC, treated with ESD;
• Mucosal defect after ESD of
a) = 50% oesophageal circumference in a patient with SCC,
or
b) = 75% oesophageal circumference in a patient with BE-HGD or EAC;
• Negative pregnancy test in females of childbearing potential at the screening visit.

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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Any prior or intended chemotherapy for oesophageal cancer;
• Any prior ESD in the area where ESD will be done;
• Any prior or intended oesophageal surgery or surgery for the mediastinum, endoscopic mucosal resection (EMR), or radio frequency ablation (RFA), in the area where ESD will be done;
• Evidence of regional lymph node metastases or distant metastases prior to ESD;
• Any prior or intended radiotherapy which involves or affects the area of ESD during the last 5 years;
•Any prior endoscopic dilation for oesophageal stenosis which involves or affects the area of ESD during the last 5 years;
• Any other concomitant oesophageal disease;
•Any severe concomitant disease, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results, or any disorder which in the opinion of the investigator might affect the patient's safety;
• Any systemic therapy for any reason that may affect assessment of primary or secondary endpoints.

Study & Design

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