NCT02990936Not yet recruiting
Prognostic Impact of Tumor Growth Velocity in Head and Neck Squamous Cell Carcinoma Treated by Radio(Chemo)Therapy
Source: ClinicalTrials.gov · Last updated 3 Oct 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to determine the impact of tumor growth velocity on the survival of patients with hea and neck squamous cell carcinoma treated by (chemo-)radiotherapy. Patients with stages I to IV oropharyngeal primary squamous cell carcinoma (OPSCC) elected for radiotherapy or radiochemotherapy with curative intent will be selected. Tumor volume and number and size of pathological neck lymph nodes (small diameter \> 1 cm) will be assessed on diagnostic CT-scan (DiCT) and treatment planning CT-scan (RtCT) using the summation of areas technique. Tumor progression and tumor doubling time will be calculated based on DiCT and RtCT. Tumor proliferation will be assessed on biopsy specimens by Ki67 immunohistochemistry and mitotic index. HPV status will be evaluated by PCR and p16 immunohistochemistry. Ulcerative or exophytic aspect will be noticed. Tumoral kinetics patterns will be correlated with disease free survival and overall survival of patients with HNSCC. These patterns will be compared to HPV status and proliferation markers in order to study their clinical signification \[time frame: 5 years\] and develop predictive markers of tumor progression for head and neck cancers.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 28 May 2015
- Start date
- 1 Nov 2019
- Primary completion date
- Nov 2024
- Lead sponsor
- Centre Hospitalier Universitaire UCLouvain Namur
- Diseases
- Head and neck cancer
- NCT number
- NCT02990936
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Nov 2019 to the primary completion date, Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- primary surgical management
Other illness
- metastatic disease
- contraindications to iodine contrast injection: anaphylaxis and renal insufficiency
Other
- tumor not visible on CT
Who the study is looking for
- clinical and anatomopathological diagnosis of a head and neck squamous cell carcinoma (T1 to T4) (oral cavity, oropharynx, larynx, hypopharynx)
- multidisciplinary decision for radiotherapy or concomitant radiochemotherapy eligibility
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Ste-Elisabeth Coordinator of this site? Confirm its status | Namur | Belgium | Unknown status |
| CHU Dinant Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.