TriangleNCT00851253 · REGISTRY CONDITION SEARCH
Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2018-01-17
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- 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)
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
- intervention Names
- Radiation: stereotactic radiosurgery
- label
- Group 1 (CK SRS boost therapy)
- type
- EXPERIMENTAL
- description
- Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
- intervention Names
- Radiation: stereotactic radiosurgery
- label
- Group 2 (CK SRS salvage therapy)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Group 1 (CK SRS boost therapy)
- Group 2 (CK SRS salvage therapy)
- description
- Given in 2 fractionated doses or 5 fractionated doses
- name
- stereotactic radiosurgery
- other Names
- CyberKnife
- type
- RADIATION
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 12
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Median time to local failure based on regional or distant metastatic disease
- measure
- Duration of Local Control
- time Frame
- 1 year
- secondary Outcomes
- description
- Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment
- measure
- Rates of Adverse Events Associated With Treatment
- time Frame
- 1 year
Full study description
- brief 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.
- detailed Description
- OBJECTIVES: * To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as boost therapy after standard chemoradiotherapy in patients with locally advanced head and neck cancer. * To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as salvage therapy in patients with locally recurrent head and neck cancer. OUTLINE: Patients are assigned to 1 of 2 treatment groups according to disease status after prior standard therapy. Patients with residual disease after standard therapy are assigned to group 1. Patients with recurrent disease ≥ 6 months after standard therapy are assigned to group 2. All patients undergo placement of 3-6 gold fiducial markers within 1-2 weeks of beginning CyberKnife® stereotactic radiosurgery (SRS) treatment. * Group 1 (CyberKnife® SRS boost therapy): Patients undergo CyberKnife® SRS boost therapy (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy. * Group 2 (CyberKnife® SRS salvage therapy): Patients undergo CyberKnife® SRS salvage therapy (5 fractions) 3 times weekly. After completion of study treatment, patients are followed periodically for up to 2 years.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-252afba09b614908fe93
- requested nct id
- NCT00851253
- primary nct id
- NCT00851253
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 38e97f6c23d7b292911d062dea3fc0dffbdcbde03aae232fe8d067fdd28034c9
- payload sha256
- 87bf0b793489a344cfed8d1e49533959ec9076f0428c7f9c4e3a97d5a5fa360d
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-252afba09b614908fe93
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT00851253
- occurrences
- context exact
- NCT00851253
- end
- 11
- exact text
- NCT00851253
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Salivary Gland Cancer
- query disease state id
- ds-salivary-gland-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-salivary-gland-cancer-000.json
- source file sha256
- 38e97f6c23d7b292911d062dea3fc0dffbdcbde03aae232fe8d067fdd28034c9
- source json pointer
- /studies/15/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 7ddd4826397bfff386fae4ccdcbd59d3884a10ceefe9f8ba6f430cb825b3c659
Preserved source evidence · Not medical advice