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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
EU CTIS ID: 2023-507897-42-00
What this study is testing
To assess the efficacy of eight weeks treatment with 2 x 1 mg/day or 2 x 2 mg/day budesonide orodispersible tablets vs. placebo for prevention of oesophageal strictures after endoscopic submucosal dissection
- Therapeutic exploratory (Phase II)
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
- 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
You likely can't join if
- Any prior or intended chemotherapy for oesophageal cancer;
- Any known relevant infectious disease (e.g., AIDS defining diseases, active tuberculosis);
- Diagnosis of chickenpox, herpes zoster or measles within the last three months prior to randomisation
- Known history of a) liver cirrhosis, b) severe renal impairment (Portugal only)
- Any of the following medical conditions (if not being sufficiently under control): cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract
- 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;
See the full eligibility criteria
Who can join
- 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;
- Women of childbearing potential agree to apply during the entire duration of the trial an effective method of birth control, which is defined as those, which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly. Such methods include implants, injectables, combined oral contraceptive method, combined contraceptive patches and vaginal rings, copper containing IUDs, sexual abstinence, or vasectomised partner. The investigator is responsible for determining whether the patient applies adequate birth control methods to allow for trial participation. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or post-menopausal with at least two years without spontaneous menses.
What rules you out
- Any prior or intended chemotherapy for oesophageal cancer;
- Any known relevant infectious disease (e.g., AIDS defining diseases, active tuberculosis);
- Diagnosis of chickenpox, herpes zoster or measles within the last three months prior to randomisation
- Known history of a) liver cirrhosis, b) severe renal impairment (Portugal only)
- Any of the following medical conditions (if not being sufficiently under control): cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract
- 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;
- a) (All countries, except Portugal:) Any systemic therapy for any reason that may affect assessment of primary or secondary endpoints, i.e., biologics, or immunosuppressants, within the last 4 weeks prior to randomisation or planned as concomitant treatment, b) (Portugal only:) Any systemic therapy for any reason that may affect assessment of primary or secondary endpoints, i.e., systemic glucocorticosteroids, biologics, or immunosuppressants, within the last 4 weeks prior to randomisation or planned as concomitant treatment
- a) (All countries, except Portugal:) Oral or intravenous systemic or oral topical glucocorticosteroids for any reason that may affect assessment of primary or secondary endpoints, which cannot be stopped at screening latest or are planned as concomitant treatment; b) (Portugal only:) Oral topical glucocorticosteroids used within the last 2 weeks prior to randomisation or planned as concomitant treatment
- Inhaled or nasal topical glucocorticosteroids for any reason that may affect assessment of primary or secondary endpoints, which cannot be stopped at screening latest or are planned as concomitant treatment for more than 7 days;
- Any therapy with cytochrome P450 3A4 (CYP3A4) inhibitors which might influence hepatic biotransformation: very potent (cobicistat, ritonavir, ketoconazole, voriconazole), potent (boceprevir, clarithromycin, itraconazole, saquinavir, telaprevir, telithromycin), or moderate (aprepitant, conivaptan, diltiazem, erythromycin, fluconazole, nefazodone, posaconazole, verapamil) administered repeatedly (i.e., > 3 days) in the last 3 weeks prior to randomisation or planned as concomitant therapy for more than 7 days;
- Any therapy with CYP3A4 inducers, which might influence hepatic biotransformation: very potent (carbamazepine, phenytoin, rifampicin), moderate (St. John’s Wort), administered repeatedly (i.e., > 3 days) in the last 3 weeks prior to randomisation or planned as concomitant therapy for more than 7 days;
- Any prior ESD in the area where ESD will be done;
- Live vaccination within the last 4 weeks prior to randomisation, or any planned live vaccination during the trial
- Intake of grapefruit containing food or beverages during the DB treatment phase
- Known intolerance/hypersensitivity/resistance to the investigational medicinal product (IMP: budesonide) or its excipients or to drugs of similar chemical structure or pharmacological profile;
- History of intolerance/hypersensitivity to propofol (if propofol will be used for sedation)
- Well-founded doubt about the patient’s cooperation
- Existing or intended pregnancy or breast-feeding;
- Participation in another clinical trial within the last 30 days prior to the screening visit, simultaneous participation in another clinical trial, or previous participation in the BUL-5 trial and having received any IMP
- 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 yea
- 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 (e.g. eosinophilic oesophagitis, oropharyngeal or oesophageal bacterial, viral, or untreated or inadequately treated fungal infection, inadequately treated candida oesophagitis or Zenker’s diverticulum);
- Achalasia, scleroderma oesophagus, or systemic sclerosis
- Necessity of oesophageal stent placement prior to randomisation;
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
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 Switzerland. 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.