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)
19 Years
N/A
Both
Salivary Gland Squamous Cell Carcinoma, Stage II Salivary Gland Cancer, Stage II Squamous Cell Carcinoma of the Hypopharynx, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Verrucous Carcinoma of the Oral Cavity, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Verrucous Carcinoma of the Oral Cavity
Trial Information
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)
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.
Inclusion Criteria:
- Histologic or cytologic confirmation of head and neck malignancy without clinical or
radiographic evidence of metastatic disease
- Locally advanced HN SCC, stages III, IV, and bulky (> 27 cm^3 volume) stage II,
excluding larynx and nasopharynx, of no more than 150 cm^3 volume base on CT scan
- All patients must be informed of the investigational nature of this study and must
give written informed consent in accordance with institutional and federal guidelines
- Candidate for chemotherapy
- Zubrod performance score of 0 or 1
- Absolute granulocyte count (AGC) >= 2000 cells/mm^3
- Platelet count >= 100,000 cells/mm^3
- Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to
registration on study
- Serum creatinine =< 1.5 mg/dl or measured or calculated creatinine clearance >= 50
ml/min
- Negative pregnancy test within 2 weeks prior to registration for women of
childbearing potential
Exclusion Criteria:
- Prior invasive malignancy except non-melanomatous skin cancers unless patient has
been disease free for at least 3 years
- Prior cancer treatment for this cancer, including gross total tumor excision
- Prior radiation treatment to the HN region
- Patients with known syndromes that alter radiosensitivity
- Any medical contraindications for chemotherapy
- Pregnant or lactating women
- Women (of childbearing potential) and men who are sexually active and are not
willing/able to use a medically acceptable form of contraception throughout the
treatment and 60 days thereafter
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Shiyu Song
Investigator Role:
Principal Investigator
Investigator Affiliation:
Virginia Commonwealth University
Authority:
United States: Food and Drug Administration
Study ID:
MCC 13222
NCT ID:
NCT01283178
Start Date:
July 2011
Completion Date:
January 2016
Related Keywords:
- Salivary Gland Squamous Cell Carcinoma
- Stage II Salivary Gland Cancer
- Stage II Squamous Cell Carcinoma of the Hypopharynx
- Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage II Squamous Cell Carcinoma of the Oropharynx
- Stage II Verrucous Carcinoma of the Oral Cavity
- Stage III Salivary Gland Cancer
- Stage III Squamous Cell Carcinoma of the Hypopharynx
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Squamous Cell Carcinoma of the Oropharynx
- Stage III Verrucous Carcinoma of the Oral Cavity
- Stage IV Salivary Gland Cancer
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Oropharynx
- Stage IV Verrucous Carcinoma of the Oral Cavity
- squamous cell carcinoma of the paranasal sinus and nasal cavity
- Carcinoma
- Carcinoma, Squamous Cell
- Carcinoma, Verrucous
- Salivary Gland Neoplasms
- Hypopharyngeal Neoplasms
- Oropharyngeal Neoplasms
Name | Location |
|---|---|
| Virginia Commonwealth University | Richmond, Virginia |
