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Optimized Intensity Modulated Irradiation for Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IMRT

Paclitaxel

Carboplatin

Cisplatin

5-Fluorouracil

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemo-IMRT

Arm 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-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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00580983

First Posted

December 25, 2007

Last Updated

July 28, 2016

Sponsor

University of Michigan Rogel Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00580983

Brief Title

Optimized Intensity Modulated Irradiation for Head and Neck Cancer

Official Title

Optimized Intensity Modulated Irradiation for Head and Neck Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

Head and Neck cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemo-IMRT

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil

Primary Outcome Measure Information:

Title

Percentage of Participants With Grade 0-1 Observer-rated Dysphagia

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures

Description

To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avraham Eisbruch, M.D.

Organizational Affiliation

University of Michigan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5010

Country

United States

12. IPD Sharing Statement

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Optimized Intensity Modulated Irradiation for Head and Neck Cancer

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