Optimized Intensity Modulated Irradiation for Head and Neck Cancer

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Cisplatin; Drug: 5-Fluorouracil; Drug: Carboplatin; Drug: Paclitaxel; Radiation: IMRT

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5010
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Chemo-IMRT; Chemotherapy: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Grade 0-1 Observer-rated Dysphagia	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures	To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.	5 years

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Avraham Eisbruch, M.D., University of Michigan Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 25, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Head and Neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Fluorouracil
• Other Study ID Numbers: UMCC 2-21; HUM 43020 Legacy 2002-513 (Other Identifier: University of Michigan IRBMED)