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

June 1, 2016 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced Squamous Cell Carcinoma of the Oropharynx: a Phase-I Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint Luc
        • Contact:
          • Vincent Grégoire, MD, PhD
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • U.Z. Leuven - Campus Gasthuisberg
        • Contact:
          • Sandra Nuyts, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation
Radiation: dose escalation
molecular imaging based radiotherapy dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute toxicity
Time Frame: up to 3 months following the completion of radiotherapy
up to 3 months following the completion of radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Primary tumor control probability
Time Frame: at 1 and 2 years
at 1 and 2 years
Late toxicity
Time Frame: at 1 and 2 years
at 1 and 2 years
Progression-free survival
Time Frame: at 1 and 2 years
at 1 and 2 years
Overall survival
Time Frame: at 1 and 2 years
at 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Vincent Grégoire, MD, PhD, 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 8, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/13MAR/117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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