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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004226
First received: January 28, 2000
Last updated: December 3, 2013
Last verified: July 2004

January 28, 2000
December 3, 2013
May 2000
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Complete list of historical versions of study NCT00004226 on ClinicalTrials.gov Archive Site
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Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy
Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck

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.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
Head and Neck Cancer
Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004226
CDR0000067467, UAB-RAD-9601, UAB-F970430006, NCI-G99-1656
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University of Alabama at Birmingham
National Cancer Institute (NCI)
Study Chair: James L. Pearlman, MD H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP