We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004226
Recruitment Status : Unknown
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy following surgery in treating patients who have recurrent or second primary cancer of the head and neck following previous radiation therapy.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:


  • Determine the survival and local control in previously irradiated patients at high risk for local failure following regional resection of recurrent or second primary head and neck cancer.
  • Determine the acute and late toxicities of this treatment in these patients.
  • Determine the pattern of disease failure in these patients on this treatment.
  • Determine any change in quality of life in these patients on this treatment.

OUTLINE: Patients receive fractionated doses of radiotherapy five times weekly for 6 weeks.

Quality of life is assessed prior to study, 2 months after radiotherapy, every 3 months for remainder of year 1, every 4 months for years 2-3, every 6 months for years 4-5, and then annually thereafter.

Patients are followed 2 months after radiotherapy, every 3 months for year 1, every 4 months for year 2, every 6 months for years 3-5, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 5 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck
Study Start Date : May 2000

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed squamous cell carcinoma of the mucosa, recurrent (primary and/or nodal), or a second primary (positive or negative nodal), of one of the following:

    • Oral cavity
    • Oropharynx
    • Hypopharynx
    • Larynx
    • Paranasal sinus
    • Neck disease of unknown origin
  • No distant metastases
  • No primary in the nasopharynx
  • Must have complete gross resection of disease
  • Must have positive final margins, soft tissue extension of primary, positive extracapsular extension of lymph node disease, or at least 4 positive nodes without extracapsular extension
  • Reirradiation field must overlap the previous field for a minimum of 3 cm in height, width, and length

    • At least 6 months since prior radiotherapy with an overlap volume of at least 45 Gy
  • No grade 3 or 4 toxicity for the following organ tissues:

    • RTOG grade 3 or 4 skin, subcutaneous tissue, larynx, joint, or RTOG grade 4 mucous membrane or bone from prior radiotherapy
  • Radiotherapy must begin within 6-12 weeks of surgery
  • Prior radiotherapy records must be available



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant
  • No history of invasive malignancy that would be expected to cause death within 3 years


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004226

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
United States, Florida
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study Chair: James L. Pearlman, MD H. Lee Moffitt Cancer Center and Research Institute

ClinicalTrials.gov Identifier: NCT00004226     History of Changes
Other Study ID Numbers: CDR0000067467
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: July 2004

Keywords provided by National Cancer Institute (NCI):
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the oropharynx
recurrent metastatic squamous neck cancer with occult primary

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site