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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02336711

Enrollment

Registered

2015-01-13

Start date

2014-11-30

Completion date

2016-09-30

Last updated

2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

Interventions

RADIATIONdose escalation

molecular imaging based radiotherapy dose escalation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Contacts

Primary ContactVincent Grégoire, MD, PhD

vincent.gregoire@uclouvain.be+ 32-2-7645431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026