Optimized Intensity Modulated Irradiation for Head and Neck Cancer

NCT00580983 | Completed Results DMC

• 2 other identifiers: UMCC 2-21HUM 43020 Legacy 2002-513
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  5 years

Study Arms (1)

Chemo-IMRT

EXPERIMENTAL

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.

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

Interventions

IMRT RADIATION

Chemo-IMRT

Paclitaxel DRUG

Chemo-IMRT

Carboplatin DRUG

Chemo-IMRT

Cisplatin DRUG

Chemo-IMRT

5-Fluorouracil DRUG

Chemo-IMRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109-5010, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Paclitaxel; Carboplatin; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

No modeling of observer-rated posttherapy dysphagia was performed because of the small number (four) of patients with greater than, or equal to, Grade 2 after 6 months.

Results Point of Contact

• Title: Dr. Avraham Eisbruch, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

eisbruch@umich.edu

734-936-4302

Study Officials

• Avraham Eisbruch, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2007
• First Posted: December 27, 2007
• Study Start: August 1, 2003
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 7, 2016
• Results First Posted: November 14, 2014

Record last verified: 2016-07

Locations

US (1)