Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck C… (NCT00851253) | Clinical Trial Compass
CompletedNot Applicable
Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
United States12 participantsStarted 2009-01
Plain-language summary
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects of stereotactic radiosurgery in treating patients with locally advanced or recurrent head and neck cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Biopsy-confirmed\* invasive head and neck cancer, including the following primary sites:
* Nasopharynx
* Oropharynx
* Paranasal sinus
* Oral cavity
* Orbit
* Salivary gland NOTE: \*Biopsy must be performed prior to initiation of external beam radiotherapy (EBRT)
* Stage T2-4 tumor at the time of diagnosis
* Primary tumor ≤ 5 cm in diameter at the time of CyberKnife® stereotactic radiosurgery (SRS)
* Meets one of the following criteria:
* Eligible for CyberKnife® SRS as boost therapy, as defined by one of the following criteria:
* Planning to undergo definitive EBRT, with or without chemotherapy, with curative intent for primary head and neck cancer
* Biopsy-confirmed locally persistent disease \< 3 months after completion of definitive EBRT
* Eligible for CyberKnife® SRS as salvage therapy\*, as defined by one of the following criteria:
* Biopsy-confirmed locally recurrent disease occurring ≥ 6 months after the completion of radiotherapy; achieved a complete response to initial therapy by imaging or clinical examination; had \> 50% of the tumor volume in the prior irradiated volume; and received \> 45 Gy of radiotherapy
* Biopsy-confirmed locally recurrent disease occurring between 6 weeks and 6 months after the completion of radiotherapy; achieved a complete response to initial therapy by imaging or clinical examination; had \< 50% of the tumor volume in the prior irradiated volume; and r…