NCT02336711UnknownNot Applicable
Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced Squamous Cell Carcinoma of the Oropharynx: a Phase-I Study.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 sites in 1 country10 target enrollmentStarted: November 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Acute toxicity
Study Overview
Brief 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.
Detailed Description
The objective is to assess the feasibility (i.e. early toxicity) of an adaptive dose escalation through 18F-FDG-PET-based dose painting by numbers in 10 HPV negative patients with locally advanced squamous cell carcinoma of the oropharynx. Treatment will be delivered with Helical Tomotherapy® or volumetric-modulated arc therapy (VMAT). Dose adaptation will be performed at 2 time-points with per-treatment 18F-FDG-PET/CT scans.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •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
Arms & Interventions
Dose escalation
Experimental
Dose escalation
Intervention: dose escalation (Radiation)
Outcomes
Primary Outcomes
Acute toxicity
Time Frame: up to 3 months following the completion of radiotherapy
Secondary Outcomes
- Late toxicity(at 1 and 2 years)
- Overall survival(at 1 and 2 years)
- Progression-free survival(at 1 and 2 years)
- Primary tumor control probability(at 1 and 2 years)
Investigators
Study Sites (2)
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