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Completed

NCT Number: NCT01344356

Stereotactic Body Radiotherapy for Head and Neck Tumors

This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.

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Key information

About this study

This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:

  • Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection
  • Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)
  • Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age > 18 years
  • Zubrod performance status of 0-3
  • Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma
  • Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma
  • Signed study-specific consent form

Exclusion criteria

  • Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
  • Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Treatment and study plan

stereotactic body radiotherapy

Radiation

14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)

Primary outcomes

  1. Local Control Rate

    Time frame: 5 years

    Complete or partial tumor response or stable disease

  2. Local Recurrence

    Time frame: 5 years

    Instances of progressive disease

  3. Complication Rate

    Time frame: 5 years

    Number of participants with any adverse event

Secondary outcomes

  1. Overall Survival

    Time frame: 5 years

    Number of participants who are alive 5 years following treatment.

Sponsors and collaborators

Lead sponsor

Mercy Research

Other

Registry information

Official study title

Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2011
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.