Optimized Intensity Modulated Irradiation for Head and Neck Cancer
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Optimized Intensity Modulated Irradiation for Head and Neck Cancer
Studies show that a dose response relationship in the salivary glands exists and that it may
be possible to improve significantly post-radiation xerostomia and quality of life if
radiation techniques can be devised that would spare the salivary glands while adequately
treating the targets. A new treatment modality (computer-optimized IMRT) facilitates
increased sparing of noninvolved tissue, specifically the sparing of both parotid glands,
and more conformal high-dose delivery to the bilateral neck targets in patients with head
and neck cancer. This study will evaluate the benefits regarding xerostomia-specific and
general QOL in patients receiving head and neck RT using this modality. Assessment of
swallowing dysfunction and aspiration will be made using videofluoroscopy. In addition, this
study will evaluate the pattern of local/regional tumor recurrence, to assess whether
sparing both parotid glands may cause tumor recurrence in spared neck areas.
Inclusion Criteria:
- All patients must have histologically confirmed invasive cancer of the head and neck.
- Irradiation to both neck sides is required.
- Standard radiation techniques would irradiate most of both parotid glands to a high
dose (>50 Gy). Patients with oropharyngeal, oral, nasopharyngeal, hypopharyngeal and
advanced laryngeal cancer are expected to fulfill this requirement.
- Patients with resectable disease that is either measurable, evaluable or
non-measurable disease (post-operative) will be eligible.
- Karnofsky performance status >60
- Patients receiving or not receiving chemotherapy are eligible.
- All patients must sign an informed consent.
- Pre-treatment laboratory criteria:
- WBC > 3500/ul, granulocyte > 1500/ul.
- Platelet count > 100,000/ul.
- Creatinine clearance > 60 cc/min. to receive cisplatin; creatinine clearance
30-59 cc/min to receive carboplatin.
- Bilirubin < 1.5 mg% with no evidence of obstructive liver disease.
- AST and ALT equal to or less than 2.5 x upper limit of normal.
Exclusion Criteria:
- Patients who received past irradiation to the head and neck are not eligible.
- Prior head and neck malignancy or history of other prior non-head and neck malignancy
within the past 3 years.
- Prior head and neck radiation or prior chemotherapy.
- Documented evidence of distant metastases.
- Active infection.
- Pregnancy or lactation; patients must use effective contraception during the course
of the clinical trial.
- Any medical or psychiatric illness which in the opinion of the principal investigator
would compromise the patients ability to tolerate this treatment.
- Patients residing in prison.
- Age < 18 years.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy.
Outcome Time Frame:
5 years
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
UMCC 2-21
NCT ID:
NCT00580983
Start Date:
August 2003
Completion Date:
January 2015
Related Keywords:
- Head and Neck Cancer
- Head and Neck cancer
- Patients with resectable disease that is either measurable, evaluable or non-measurable disease (post-operative) for patients with head and neck cancer
- Head and Neck Neoplasms
Name | Location |
|---|---|
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
