Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the… (NCT02336711) | Clinical Trial Compass
UnknownNot Applicable
Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx
Belgium10 participantsStarted 2014-11
Plain-language summary
Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients older than 18 years
* Patients with squamous cell carcinoma of the oropharynx, HPV-negative (p16 assay)
* T size of 3 cm or more in greatest dimension with the exclusion of tumor with bone infiltration
* N0, N1, N2a, N2b node (AJCC/UICC 7th edition)
* No distant metastasis
* No contra-indication to concomitant chemotherapy
* World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥ 80.
* Provision of written informed consent
Exclusion Criteria:
* Patients with induction chemotherapy will not be eligible
* Previous or concurrent history of cancer, except basal cell skin carcinoma
* Second primary tumor at the time of diagnosis
* Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
* Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
* Pregnant or lactating women
What they're measuring
1
Acute toxicity
Timeframe: up to 3 months following the completion of radiotherapy