Clinical trial · Interventional
Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (CK SRS boost therapy)
- description
- Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
- interventionNames
- Radiation: stereotactic radiosurgery
- type
- EXPERIMENTAL
- label
- Group 2 (CK SRS salvage therapy)
- description
- Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
- interventionNames
- Radiation: stereotactic radiosurgery
Primary outcomes (1)
- measure
- Duration of Local Control
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 received \> 45 Gy of radiotherapy NOTE: \*Not a candidate for salvage surgery or brachytherapy
* Anticipated total dose of radiotherapy to the spinal cord ≤ 50 Gy (including prior dose)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to achieve normal tissue tolerance to critical structures with the CyberKnife® planning system
* Able to undergo CT simulation
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Exclusion Criteria:
* No laryngeal or hypopharyngeal cancer
* No evidence of distant metastases
* No prior brachytherapy
* No prior CyberKnife® SRS boost or salvage therapy
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No active connective tissue disorders (e.g., lupus or scleroderma)References
Publications (0)
Data not yet available