A Phase I Dose Escalation Trial: Concurrent Intensity-Modulated Radiotherapy (IMRT) and Chemotherapy With Molecular Image-Guided Adaptive Radiation Therapy (IGART) for Advanced Head and Neck Squamous Cell Carcinomas (HNSCC)
I. To determine the feasibility of integrating molecular imaging (PET with FLT tracer) into
current state-of-the-art image-guided adaptive radiation therapy (IGART) of head and neck
II. To determine within a predefined range the maximum tolerated radiation dose for
concurrent cisplatin and molecular and anatomic image-based IGART of head and neck cancer.
SECONDARY OBJECTIVES I. To compare gross tumor volumes defined by FDG-PET, FLT-PET, CBCT,
and regular FBCT before, during, and following completion of chemo-radiation therapy.
II. To evaluate the impact of escalated doses to tumor sub-volumes with high FLT and FDG
uptake prior to and during radiation therapy using post-treatment FDG images as an early
surrogate for sub-volume-specific local control.
III. To develop a database consisting of all molecular and anatomic images, including daily
CBCT data sets, obtained during chemo-radiation therapy to support further research.
Potential applications include determination of optimal adaptive re-planning frequency and
the benefits of basing IGART on 4D anatomic data sets derived from deformably registering
daily CBCT and FBCT data sets.
IV. Determine patient long-term toxicities and survival. V. To evaluate the impact of daily
image-guided setup; off-line every other week adaptive re-planning; and molecular-image
based targeting on sparing of tissues and organs responsible for late and early treatment
OUTLINE: This a dose-escalation study of intensity-modulated radiotherapy.
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a
week for 6 weeks. Patients also receive cisplatin IV on days 1 and 22. Treatment continues
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 and 4 weeks, 2, 3, 4, 5,
6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of integrating molecular imaging (PET with FLT tracer) into current state-of-the-art image-guided adaptive radiation therapy (IGART) of head and neck cancer
Virginia Commonwealth University
United States: Food and Drug Administration
|Virginia Commonwealth University||Richmond, Virginia|