Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Radiation: dose escalation

Study type: Interventional

Funder types: Other

Identifiers

NCT02336711

2013/13MAR/117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Dose escalation

Experimental group

Description:

Dose escalation

Treatment:

Radiation: dose escalation