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
ClinicalTrials.gov Identifier:
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.

Condition Intervention
Head and Neck Cancer
Radiation: IMRT
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Drug: 5-Fluorouracil

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimized Intensity Modulated Irradiation for Head and Neck Cancer

Resource links provided by NLM:

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Percentage of Participants With Grade 0-1 Observer-rated Dysphagia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.

Secondary Outcome Measures:
  • The Mean Esophageal Dose in Patients With Strictures and Without Strictures [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To assess the relationships between the mean dose delivered and objectively measured dysphagia.

Enrollment: 90
Study Start Date: August 2003
Estimated Study Completion Date: May 2016
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemo-IMRT


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.

Radiation: IMRT Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: 5-Fluorouracil

Detailed Description:
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00580983

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-5010
Sponsors and Collaborators
University of Michigan Cancer Center
Principal Investigator: Avraham Eisbruch, M.D. University of Michigan Hospital
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00580983     History of Changes
Other Study ID Numbers: UMCC 2-21  HUM 43020 Legacy 2002-513 
Study First Received: December 25, 2007
Results First Received: November 5, 2014
Last Updated: November 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
Head and Neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016