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
Status | Terminated |
Enrollment | 3 |
Est. completion date | September 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 weeks | No | |
Secondary | Comparison of gross tumor volumes defined by FDG-PET, FLT-PET, CBCT, and regular FBCT | Before, during, and following completion of chemoradiation therapy | No | |
Secondary | Impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake using post-treatment FDG images as an early surrogate for sub-volume-specific local control | Prior to and during radiation therapy | No | |
Secondary | Development of a database consisting of all molecular and anatomic images, including daily CBCT data sets, obtained during chemo-radiation therapy to support further research | Up to 5 years | No | |
Secondary | Patient long-term toxicities and survival | 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 | Yes | |
Secondary | 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 | 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 | No |
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