1. To evaluate the feasibility of cryoballoon therapy in patients with incurable esophageal carcinoma and symptoms of dysphagia, defined as technical success rate. In addition, the efficacy and safety will be assessed by looking at the clinical…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Feasibility: defined as technical success rates of a full cryotherapy
procedure. This includes the ability to pass the scope and the completion of a
full circle of freezing and thawing, with the number of cycles needed per site
as deemed necessary by the endoscopist
2. Efficacy
- Subjective parameters based on clinical success rate at week 2 after last
therapy, using the 5 point Likert dysphagia score (0= no dysphagia, 1=
dysphagia to solids, 2= dysphagia to semisolids, 3= dysphagia to liquids, 4=
dysphagia to saliva). An improvement of one point is considered as clinical
success.
- Objective parameters:
- Ability of the diagnostic endoscope to pass
- Percentage of the diameter of the esophageal lumen that is open/ free
from tumor, as assessed by the treating endoscopist and two independent
assessors, comparing pre- and post-treatment.
3. Safety based on incidence of all serious adverse events up to the end of
follow-up
Secondary outcome
Feasibility, efficacy and safety:
• Efficacy based on subjective parameters
o Reported outcomes on dysphagia scores twice weekly, up to two weeks after
endoscopy, and thereafter at week 6, 8 and 12.
o General questions, twice weekly, up to two weeks after last treatment:
* How do you experience your symptoms now compared to before treatment (0=
symptoms got significantly worse, 1= symptoms got slightly worse, 2= symptoms
remained the same, 3, symptoms slightly improved, 4= symptoms significantly
improved, 5= symptoms fully disappeared)
* How do you experience your symptoms now compared to yesterday (0= symptoms
got significantly worse, 1= symptoms got slightly worse, 2= symptoms remained
the same, 3, symptoms slightly improved, 4= symptoms significantly improved)
• Post procedural pain based on twice weekly pain scores up to two weeks after
last treatment
o Pain at the area of the esophageal tumor during meals based on a NRS 0-10
(with 0 indicating no pain and 10 indicating unbearable pain)
o Pain at the area of the esophageal tumor when not eating/at rest using the
same score as above
• Incidence of AE*s, defined as any undesirable experience occurring to a
subject following treatment and/or that are secondary to the treatment. All
adverse events reported spontaneously by the subject or observed by the
investigator/ staff will be recorded.
• Necessity of receiving any other kind of palliation for dysphagia during
follow-up
Immunology:
• (Changes in) Host*s anti-tumor response after cryoballoon ablation compared
to baseline.
Background summary
Dysphagia is commonly encountered in patients with esophageal carcinoma who are
no candidates for treatment with curative intent. It often has a considerable
impact on quality of life and can cause malnourishment. Current palliative
treatments mainly include esophageal stenting and radiotherapy, but these can
be associated with substantial drawbacks such as a high rate of adverse events,
fatigue or an untimely/ temporary symptom improvement. Recent studies showed
promising results for the use of spray cryotherapy as palliation for dysphagia.
Moreover, there are suggestions that cryotherapy has a positive effect on the
host*s anti-tumor response. However, no data exists on the feasibility,
efficacy, safety for cryoballoon therapy in the esophagus. Secondly,
cryo-immunologic data in patients with EC is lacking.
Study objective
1. To evaluate the feasibility of cryoballoon therapy in patients with
incurable esophageal carcinoma and symptoms of dysphagia, defined as technical
success rate. In addition, the efficacy and safety will be assessed by looking
at the clinical success rate 2 weeks post-therapy, regression of tumor in the
esophageal lumen, and lastly occurrence of serious adverse events (SAE*s).
2. To evaluate the host anti-tumorresponse after cryotherapy on tumor biopsies
and in peripheral blood samples
Study design
Multi-center Prospective Uncontrolled Interventional Pilot Study. Patients will
be identified during the RAKU (Regionaal Academisch Kankercentrum Utrecht)
multi-disciplinary team meeting held at weekly intervals at the University
Medical Center Utrecht, or at a multidisciplinary team meeting in the Amsterdam
University Medical Center (GIOCA).
Study procedures will be performed in the University Medical Center Utrecht or
the Amsterdam University Medical Center. The study procedures differ partly for
patients in the UMCU compared to patients in the Amsterdam UMC:
- Patients in both centers will receive a maximum successive of 3 cryoballoon
treatments at a two-weekly interval (range between 1 and 3 weeks). Two weeks
after the last treatment session, a follow-up endoscopy is performed.
- Only in patients at the UMC Utrecht peripheral blood samples and tumor
biopsies will be taken during every endoscopy session. From these patients,
biopsies and blood samples will later be analyzed to evaluate the host*s
anti-tumor response.
- For both patients in both treatment centers counts that clinical follow up
will be extended until 3 months after the last treatment session.
Our aim is to conduct the study within 6 months.
Intervention
For all treatments the C2 Focal CryoBalloonTM will be used. The intervention
consists of 3 subsequent treatments with an interval of 1-3 weeks. During each
treatment session, two freeze-thaw cycles of 12 seconds will be performed per
treatment site. The number of cycles could be increased depending on the need
as assessed by the endoscopist, indubitably also taking into account safety.
Next to this, during endoscopy, tumorbiopsies will be taken only in patients at
the UMC Utrecht. All treatment procedures will be done by an endoscopist with
extensive experience with cryoballoon ablation.
Study burden and risks
Patients are required to visit the hospital three times (range 1-3) for a
treatment session and one time for a follow-up endoscopy. These treatment
sessions, if showing the expected effect, might replace palliative treatments
that patients otherwise would receive. In a subset of patients (patients in the
UMCU), peripheral blood samples and tumor biopsies will be taken during each
hospital visit for the endoscopy. Furthermore, patients are asked to answer
five short questions electronically twice a week. Besides this, patients will
be called once, by a research nurse, after every treatment session to evaluate
symptoms and adverse events. Cryoballoon therapy has been shown to be safe in
previous studies for the treatment of Barrett*s esophagus. We do not anticipate
that patients are exposed to a higher risk compared to other patients receiving
cryoballoon therapy. Moreover, spray cryotherapy has already shown promising
results for the treatment of dysphagia in patients with esophageal cancer and
there are indications that cryotherapy has a positive effect on the anti-tumor
response. In addition, other palliative options such as stenting and
radiotherapy are not free of drawbacks and have potential (serious) side
effects, temporary/untimely symptom improvement, and a sometimes even a lower
quality of life.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Age >18 years at time of consent Histopathologically-confirmed esophageal /
gastroesophageal cancer Patients in the palliative setting (with or without
(future) systemic chemotherapy) Dysphagia defined as a score of >=2 (able to
swallow only semi-solids) Signed written informed consent
Exclusion criteria
Alternative etiology for dysphagia Inability to pass ultraslim endoscope Severe
medical comorbidities precluding endoscopy Uncorrected coagulopathy Prior
distal esophagectomy Expected survival <6 weeks Prior radiotherapy for
esophageal cancer T4b esophageal cancer
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84764.041.24 |