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New treatment option for Esophageal Cancer
Official title Perioperative SDD to Prevent Infectious Complications After Esophagectomy
ClinicalTrials.gov ID: NCT05865743
What this study is testing
What is SDD?
SDD is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for esophageal cancer.
Also referred to as Standard of care.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the...
- Age ≥ 18 years,
- Able to give written informed consent.
You likely can't join if
- Patients planned for rescue surgery,
- Patients planned for colonic interposition,
- Known or suspected pregnancy,
- Patients who have undergone upper GI surgery within 30 days before randomization,
- Unable to understand the study information, study instructions and give informed consent.
- Patients enrolled in a trial that would interact with the intervention
See the full eligibility criteria
- Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the gastro-esophageal junction scheduled for undergoing transthoracic...
- Age ≥ 18 years,
- Able to give written informed consent.
- Patients planned for rescue surgery,
- Patients planned for colonic interposition,
- Known or suspected pregnancy,
- Patients who have undergone upper GI surgery within 30 days before randomization,
- Unable to understand the study information, study instructions and give informed consent.
- Patients enrolled in a trial that would interact with the intervention
- Patients with a known allergy, sensitivity, or interaction to investigational medicinal product.
- Patients with known/documented colonization of Enterobacteriaceae and or Pseudomonas Aeruginosa that are resistant to both tobramycin/gentamicin and to carbapenem antibiotics
- Patients undergoing CVVH.
- Patients with documented chronic renal failure (GFR \< 15 mls/min) or who are on chronic intermittent hemo- or peritoneal dialysis,
- Women of childbearing potential at risk of pregnancy, not using adequate contraception,
- Patients with the inability to swallow the SDD
- Patients with pre-existing degenerative neuromuscular diseases like, but not limited to, myasthenia gravis or Parkinson disease).
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Nijmegen, Netherlands
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Nijmegen, Netherlands. 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 ClinicalTrials.gov; the study team decides eligibility.