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

NCT ID: NCT02336711

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-09-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose escalation

Dose escalation

Group Type: EXPERIMENTAL

dose escalation

Intervention Type: RADIATION

molecular imaging based radiotherapy dose escalation

Interventions

dose escalation

molecular imaging based radiotherapy dose escalation

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Grégoire, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Site Status: RECRUITING

U.Z. Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status: NOT_YET_RECRUITING

Countries

Belgium

Central Contacts

Vincent Grégoire, MD, PhD

Role: CONTACT

vincent.gregoire@uclouvain.be

+ 32-2-7645431

Facility Contacts

Vincent Grégoire, MD, PhD

Role: primary

Sandra Nuyts, MD, PhD

Role: primary

Other Identifiers

2013/13MAR/117

Identifier Type: -

Identifier Source: org_study_id