No registrations found.
ID
Source
Brief title
Health condition
Esophageal squamous cell carcinoma, head and neck cancer, second primary tumor, screening, Lugol chromoendoscopy
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of synchronous esophageal second primary tumors in patients with head and neck squamous cell carcinoma
Secondary outcome
1. The prevalence of esophageal second primary tumors that can be curatively treated with minimally invasive endoscopic treatment or neoadjuvant therapy or surgery
2. The prevalence of metachronous esophageal second primary tumors found during follow-up.
3. The proportion of adjusted treatment plans of the index head and neck squamous cell carcinoma in patients diagnosed with an esophageal second primary tumor
4. 5-year survival rate
Background summary
This screening study will prospectively evaluate the effect of esophageal screening of patients with head and neck squamous cell carcinoma. We expect to find more early stage esophageal second primary tumors which can be treated curatively by endoscopic treatment.
Study objective
We hypothesize that esophageal screening with Lugol chromoendoscopy, in all patients with oro- and hypopharyngeal head and neck squamous cell carcinoma or alcohol abuse, will result in an increased detection rate of esophageal second primary tumors in asymptomatic and more early stages of disease
Study design
Time frame: approximately 3,5 year
Intervention
Lugol chromoendoscopy after diagnosis of head and neck squamous cell carcinoma and after 1 year.
P.O. Box 2040
Steffi van de Ven
Rotterdam 3000 CA
The Netherlands
s.vandeven@erasmusmc.nl
P.O. Box 2040
Steffi van de Ven
Rotterdam 3000 CA
The Netherlands
s.vandeven@erasmusmc.nl
Inclusion criteria
- HPV-negative oropharynx tumor
- Hypopharynx tumor
- When a patient has two tumors located in the head and neck region; at least one tumor has to be located in the oropharynx or hypopharynx
- Alcohol abuse (defined as > 15 units/week), regardless of the head and neck sublocation.
- Age > 18 years
- Treated with a curative intent
- Written informed consent
Exclusion criteria
- Patient with a history of previous esophageal cancer
- Contraindication for endoscopy or biopsy (esophageal varices, major coagulation disorders which cannot be corrected)
- In the patient can no longer be treated curatively for the head and neck cancer
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 |
---|---|
NTR-new | NL7299 |
NTR-old | NTR7508 |
Other | : MEC-2018-1243 |