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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02336711
• Other study ID #: 2013/13MAR/117
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2015
• Last updated: June 1, 2016
• Start date: November 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Vincent Grégoire, MD, PhD
• Phone: + 32-2-7645431
• Email: vincent.gregoire[@]uclouvain.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• dose escalation
molecular imaging based radiotherapy dose escalation

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	U.Z. Leuven - Campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity		up to 3 months following the completion of radiotherapy	Yes
Secondary	Primary tumor control probability		at 1 and 2 years	No
Secondary	Late toxicity		at 1 and 2 years	Yes
Secondary	Progression-free survival		at 1 and 2 years	No
Secondary	Overall survival		at 1 and 2 years	No