search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
dose escalation
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cliniques Universitaires Saint LucRecruiting
  • U.Z. Leuven - Campus Gasthuisberg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose escalation

Arm Description

Dose escalation

Outcomes

Primary Outcome Measures

Acute toxicity

Secondary Outcome Measures

Primary tumor control probability
Late toxicity
Progression-free survival
Overall survival

Full Information

First Posted
January 8, 2015
Last Updated
June 1, 2016
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
search

1. Study Identification

Unique Protocol Identification Number
NCT02336711
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation
Arm Type
Experimental
Arm Description
Dose escalation
Intervention Type
Radiation
Intervention Name(s)
dose escalation
Intervention Description
molecular imaging based radiotherapy dose escalation
Primary Outcome Measure Information:
Title
Acute toxicity
Time Frame
up to 3 months following the completion of radiotherapy
Secondary Outcome Measure Information:
Title
Primary tumor control probability
Time Frame
at 1 and 2 years
Title
Late toxicity
Time Frame
at 1 and 2 years
Title
Progression-free survival
Time Frame
at 1 and 2 years
Title
Overall survival
Time Frame
at 1 and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Grégoire, MD, PhD
Phone
+ 32-2-7645431
Email
vincent.gregoire@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Grégoire, MD, PhD
Organizational 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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Grégoire, MD, PhD
Facility Name
U.Z. Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Nuyts, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs