Optimized Intensity Modulated Irradiation for Head and Neck Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Michigan Cancer Center
First received: December 25, 2007
Last updated: November 6, 2015
Last verified: November 2015
The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy.
Head and Neck Cancer
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Optimized Intensity Modulated Irradiation for Head and Neck Cancer
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00580983
|University of Michigan
|Ann Arbor, Michigan, United States, 48109-5010 |
University of Michigan Cancer Center
||Avraham Eisbruch, M.D.
||University of Michigan Hospital
||University of Michigan Cancer Center
History of Changes
|Other Study ID Numbers:
HUM 43020 Legacy 2002-513
|Study First Received:
||December 25, 2007
|Results First Received:
||November 5, 2014
||November 6, 2015
||United States: Institutional Review Board
Keywords provided by University of Michigan Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 25, 2016
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs