Evaluation of cytology-based tumor resection for the surgical treatment of head and neck squamous cell carcinoma (HNSCC) patients

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00013507
• Date of registration: 01/12/2017
• Prospective Registration: Yes
• Primary sponsor: Universitätsklinikum des SaarlandesKlinik für HNO-Heilkunde
• Public title: Evaluation of cytology-based tumor resection for the surgical treatment of head and neck squamous cell carcinoma (HNSCC) patients
• Scientific title: Evaluation of cytology-based tumor resection for the surgical treatment of head and neck squamous cell carcinoma (HNSCC) patients
• Date of first enrolment: 18/12/2017
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00013507
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany, Luxembourg

Contacts

• Name: Maximilian Linxweiler
• Affiliation: Universitätsklinikum des SaarlandesKlinik für HNO-Heilkunde

• Name: Maximilian Linxweiler
• Affiliation: Universitätsklinikum des SaarlandesKlinik für HNO-Heilkunde

Key inclusion & exclusion criteria

Inclusion criteria: cT1-2 squamous cell carcinoma of the oral cavity or the oropharynx (tonsil, base of tongue, soft palate); swab cytology feasible in an outpatient setting; planned surgical treatment; no necessarity of a plastic defect coverage by a free or pedicled flap transplant; signed informed consent; Age of 18 years or higher and unlimited legal capacity
Exclusion criteria: Primary tumor in a region outside of the oral cavity or oropharynx; cT3 or higher staged Tumors; no clinical evidence for a malignant disease; swab cytology not feasible in an outpatient setting; no planned surgical treatment; necessarity of a plastic defect coverage with a free or pedicled flap transplant; lack of signed informed consent; age < 18 years or limited legal capacity; pregnancy

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

C10.9

C06.9
C10.9

C06.9

Mouth, unspecified

Oropharynx, unspecified

Intervention(s)

Group 1: Cytological tumor swab in an outpatient setting; if cytology shows a positive finding (tumor cells), a panendoscopy + rapid section histology will be performed; if rapid section histology is positive, a transoral tumor resection in the same operation will be performed (intervention arm)
Group 2: Confirmation of clinical diagnosis by panendoscopy + biopsy; transoral tumor resection in a second operation if histology is positive (control arm)

Primary Outcome(s)

time span between clinical diagnosis and definitive surgical treatment

Secondary Outcome(s)

Overall survival, progression free survival (5 years follow-up), whole time span of treament, diagnostic sensitivity of liquid-based cytology for the diagnosis of HNSCC

Source(s) of Monetary Support

Universitätsklinikum des SaarlandesKlinik für HNO-Heilkunde

Ethics review

Status: Approved
Approval date: 21/04/2017
Contact:

Results

• URL: http://drks.de/search/en/trial/DRKS00013507#studyResults