Expired Study
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Ann Arbor, Michigan 48109


Purpose:

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 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 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.


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.


Study is Available At:


Original ID:

UMCC 2-21


NCT ID:

NCT00580983


Secondary ID:

HUM 43020 Legacy 2002-513


Study Acronym:


Brief Title:

Optimized Intensity Modulated Irradiation for Head and Neck Cancer


Official Title:

Optimized Intensity Modulated Irradiation for Head and Neck Cancer


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Actual


Overall Contact Information

Official Name:Avraham Eisbruch, M.D.
Principal Investigator
University of Michigan Hospital

Study Dates

Start Date:August 2003
Completion Date:January 2015
Completion Type:Anticipated
Primary Completion Date:June 2010
Primary Completion Type:Actual
Verification Date:November 2014
Last Changed Date:November 13, 2014
First Received Date:December 25, 2007
First Results Date:November 5, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To Assess the Relationships Between the Doses Delivered to the Dysphagia/Aspiration-related Structures and Objectively Measured Dysphagia and Aspiration.
Time Frame:5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Percentage of Participants With Grade 0-1 Observer-rated Dysphagia
Time Frame:12 months
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Radiation
Name:IMRT
Arm Name:Chemo-IMRT
Intervention Type:Drug
Name:Paclitaxel
Arm Name:Chemo-IMRT
Intervention Type:Drug
Name:Carboplatin
Arm Name:Chemo-IMRT
Intervention Type:Drug
Name:Cisplatin
Arm Name:Chemo-IMRT
Intervention Type:Drug
Name:5-Fluorouracil
Arm Name:Chemo-IMRT

Study Arms

Study Arm Type:Experimental
Arm Name:Chemo-IMRT
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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