Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial
Official title:
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)
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans
and treatment-planning systems may help in planning radiation therapy. Drugs used in
chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Giving radiation therapy
together with cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of
intensity-modulated image guided adaptive radiation therapy when given together with
cisplatin in treating patients with locally advanced head and neck squamous cell cancer
PRIMARY OBJECTIVES:
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
cancer.
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
sequelae.
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
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