Clinical trial NCT02336711: Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx
Official title: Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced Squamous Cell Carcinoma of the Oropharynx: a Phase-I Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute toxicity
timeFrame: up to 3 months following the completion of radiotherapy
Secondary outcomes:
measure: Primary tumor control probability
timeFrame: at 1 and 2 years
measure: Late toxicity
timeFrame: at 1 and 2 years
measure: Progression-free survival
timeFrame: at 1 and 2 years
measure: Overall survival
timeFrame: at 1 and 2 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Leuven
country: Belgium
facility: U.Z. Leuven - Campus Gasthuisberg
Study officials:
affiliation: Department of Radiation Oncology, and Center for Molecular Imaging, Radiotherapy and Oncology (MIRO), Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain, St-Luc University Hospital, Brussels, Belgium
name: Vincent Grégoire, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: