The aim of this prospective study is the prevention of progression of premalignant lesions to invasive head and neck cancer by modifying the out-patient follow up and patient management.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal of this prospective study is:
(1) Demonstrating the predictive value of the detection of CIN in premalignant
lesions of the oral cavity by the use of FISH for the occurrence of progression
to severe dysplasia /CIS or invasive carcinoma.
(2) The prevention of progression of premalignant lesions of the oral cavity to
severe dysplasia / CIS or invasive carcinoma by the treatment of selected
high-risk lesions.
Secondary outcome
The secondary objective of this study is as follows:
(3) Demonstrating the predictive value of the detection of LOH in premalignant
lesions of the oral cavity by the use of DNA markers for the occurrence of
progression to severe dysplasia / CIS or invasive carcinoma.
(4) Conducting a primary and secondary cost analysis.
Background summary
Summarized we can say that head and neck carcinomas despite improvements in
therapy still have a poor prognosis with a 5-year survival of ~ 50%.
Malignancies of the head and neck area are (almost) always preceded by
precursorlesions. Treatment of these premalignant mucosal abnormalities is
generally limited and not very inconvenient for the patient. If this precursor
lesion remain untreated, it may develop into a malignancy of the head and neck.
Extensive treatment will be necessary. This means loss of function of the
mouth, eg chewing, speaking and swallowing.
Our hypothesis is that CIN detected by FISH is a reliable indicator for
progression to malignancy. By intensifying the follow up and treatment in
premalignant CIN lesions, the incidence of progression to invasive carcinoma is
expected to be significantly reduced. If this hypothesis is justified, there
will be a place for CIN detection as a risk indicator in the diagnostic work up
of premalignant lesions in the head and neck.
Our second hypothesis is that LOH detected bij DNA markers is a reliable
indicatior for progression to malignancy. By intensifying the outpatient clinic
follow up and treatment in premalignant lesions, the incidence of progression
to invasive carcinoma is expected to be significantly reduced. If this
hypothesis is justified, there will be a place for CIN and LOH detection as a
risk indicator in the diagnostic work up of premalignant lesions in the head
and neck.
Study objective
The aim of this prospective study is the prevention of progression of
premalignant lesions to invasive head and neck cancer by modifying the
out-patient follow up and patient management.
Study design
This is an open randomised controlled trial with parallel groups.
Intervention
Fifty percent of patients with a CIN-positive lesion will be admitted to the
ward for 1 day when they are treated, under general anesthesia, via an excision
or CO2 laser evaporisation of the mucosal lesion of the oral cavity.
Furthermore, all patients (CIN-positive and CIn-negative) are subjected to an
intensified outpatient clinic follow up.
Study burden and risks
Burden:
If a subject is assigned to the intervention group, he will undergo a(n)
(extra) surgical procedure under general anesthesia to remove the mucosal
lesion. Several risks apply to this procedure. General anesthesia may lead to
nausea and vomiting after the procedure, or a sore throat from the ventilation
tube. Rare cases of allergic reactions to medicines occur. The surgical
procedure might cause an infection or a bleeding after surgery. Pain may occur.
During 5 years subjects will be seen at the outpatient clinic, in total sixteen
visits are scheduled. Physical examination of the head and
neck region will be performed by an otorhinolaryngologist.
Benefit:
Because of close surveillance of subjects and treatment of CIN-positive lesions
in the intervention group, a decrease in the frequency of malignant outgrowth
will be expected. Therefore, subjects will have less chance to develop a
malignancy at the head and neck region and extensive treatment or (lifelong)
side effects of cancer treatment will be prevented.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Subject has a minimal age of 18 years
premalignant laesion of the oropharynx, classified as hyperkeratosis, hyperplasia, mild or moderate dysplasia
Singned informed consent form
Exclusion criteria
Prior malignancy or laesion classified as severe dysplasia or carcinoma in situ at the same anatomical location of the oropharynx.
Prior treatment of laesions at the same anatomical location of the oropharynx (ie radiotherapy)
Insufficient biopsy material to perform a FISH analysis.
Pregnancy, based on physical load (ie extra anesthaesia)
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT02238574 |
| CCMO | NL46343.068.13 |