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A Randomized Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

A Randomized Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy


Patients will be treated with definitive external beam radiation plus/minus chemotherapy
plus/minus neck dissection in the ipsilateral neck (post radiation). The primary site will
be treated with definitive radiation therapy, or definitive surgery plus post-operative
radiation therapy. Primary endpoints are loco-regional control, as well as quality of life,
xerostomia, mucositis, and neck fibrosis.

Salivary evaluations shall be performed prior to the initiation of radiation therapy, during
the second week of EBRT, and at the completion of radiation. Evaluations will also be
conducted at 3, 6, and 12 months after the completion of EBRT.

Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT.
Evaluations will also be conducted at 3 and 6 months after the completion of EBRT. Two
standardized mucositis scales will be used: the RTOG scale and the WHO scale.

Clinical response will be evaluated by physical exam and PET/CT. PET/CT scans will be done
at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.


Inclusion Criteria:



- Squamous cell carcinoma of the oral cavity or oropharynx, with the primary lesion >1
cm from the midline.

- Patient has no clinical or radiologic evidence of contralateral neck node metastases.

- No evidence of distant metastasis.

- No previous history of radiation therapy or chemotherapy

- performance status 0-2

- Age >= 18

- Signed informed consent

- Patients must be accessible for treatment and follow-up

Exclusion Criteria:

- HIV positive patients

- Pregnancy or any patients not practicing contraception

- Active tobacco or alcohol addiction (as assessed by medical caregiver)

- Serious comorbid disease which prevents delivery of full treatment including
psychiatric disorders, cardiopulmonary disease, etc.

- Concomitant use of any trial anticancer therapeutic within 30 days of entry

- Uncontrolled hypertension

- Known hypersensitivity to mammalian cell-derived products

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

FACT (head and neck);Xerostomia related Quality of Life Questionnaire

Outcome Time Frame:

September 2010

Safety Issue:

No

Principal Investigator

Louis B Harrison, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology at Beth Israel Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

186-03

NCT ID:

NCT00206752

Start Date:

August 2004

Completion Date:

February 2023

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Beth Israel Medical CenterNew York, New York  10003