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Search / Trial NCT00580983

Optimized Intensity Modulated Irradiation for Head and Neck Cancer

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Dec 26, 2007

Trial Information

Current as of May 04, 2025

Completed

Keywords

Head And Neck Cancer

ClinConnect Summary

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 regardin...

Gender

ALL

Eligibility criteria

  • 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 (White Blood Cell) \> 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 (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) 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.

About University Of Michigan Rogel Cancer Center

The University of Michigan Rogel Cancer Center is a leading academic research institution dedicated to advancing cancer treatment and prevention through innovative clinical trials. As a National Cancer Institute-designated Comprehensive Cancer Center, it combines cutting-edge research, state-of-the-art facilities, and a multidisciplinary team of experts to deliver personalized care and foster groundbreaking discoveries. The center's commitment to improving patient outcomes is reflected in its robust portfolio of clinical trials, which explore novel therapies and enhance understanding of cancer biology. Through collaboration with patients, researchers, and healthcare professionals, the Rogel Cancer Center aims to translate scientific insights into transformative therapies, ultimately contributing to the global fight against cancer.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Avraham Eisbruch, M.D.

Principal Investigator

University of Michigan Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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