Molecular Imaging-based Dose Escalation in HPV Negative P... | NCT02336711

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

NCT02336711

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

Jun 3, 2016Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Head and Neck Cancer

Interventions

dose escalation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jan 8, 2015

First Submission Date that Met QC Criteria

Jan 8, 2015

First Posted Date

Jan 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2016

Last Update Posted Date

Jun 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose escalation	Experimental	Dose escalation	Radiation: dose escalation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dose escalation	Radiation	molecular imaging based radiotherapy dose escalation	Dose escalation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vincent Grégoire, MD, PhD	Contact	+ 32-2-7645431		vincent.gregoire@uclouvain.be

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint Luc	Recruiting	Brussels		1200	Belgium

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms