Official Title
Prospective Study Evaluating ctDNA as a Biomarker for Treatment Response in Head and Neck Squamous Cell Carcinoma'
Brief Title
ctDNA as a Biomarker for Treatment Response in HNSCC
Protocol ID
NCT03540563
Lead Sponsor
The Netherlands Cancer Institute
Brief Summary
Tumours continually shed DNA into the circulation, where it can be accessed. This
circulating tumour DNA (ctDNA) directly reflects tumour burden and has great potential to
be a sensitive biomarker for treatment recurrence. These "liquid biopsies" could give a
more real-time picture of the genomic status and evolution of a tumour and can be easily
assessed for measurement of different biomarkers. However, in head and neck squamous cell
carcinoma (HNSCC) patients treated with primary curative radiotherapy, data regarding
ctDNA kinetics and its correlation with outcome are scarce. A new or additional tool for
response evaluation next to or instead of conventional imaging after treatment would be
beneficial to detect recurrences in an earlier stage, thereby increasing the chances of
success of salvage therapy. More importantly, an early response parameter during
treatment could help to identify patients that have a good treatment response and might
benefit from treatment adaptation. With this study, we aim to reveal ctDNA as an
effective tool for future dose (de)-escalation trials in HNSCC.
Study Period
-
Enrollment Count
70 participants
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age
- Stage II-IV carcinoma of the larynx, hypopharynx, oral cavity or HPV negative
oropharynx or stage II-III HPV positive oropharyngeal carcinoma, histologically
confirmed according to the American Joint Committee on Cancer (AJCC) staging manual
8th edition
- Indication for primary curative radiotherapy with or without concurrent radio
sensitizer
- WHO performance status 0-2
- Signed written IC
Exclusion Criteria:
- Metastatic disease
- Radiotherapy with palliative intent
- Diagnosis of any other malignancy within 5 years prior to start of treatment except
for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on
surveillance with no plans for treatment intervention (e.g. surgery, radiation or
castration).
Filters
Carcinoma, Squamous Cell of Head and Neck
NA
COMPLETED
ADULT
OLDER_ADULT