TriangleNCT01344356 · REGISTRY CONDITION SEARCH
Stereotactic Body Radiotherapy for Head and Neck Tumors
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE4
- Status at capture
- COMPLETED
- Registry last update
- 2020-04-10
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.
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: * 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Benign head and neck tumors will be treated with SBRT
- intervention Names
- Radiation: stereotactic body radiotherapy
- label
- Benign Tumors
- type
- OTHER
- description
- Malignant Head and Neck Tumors will be treated with SBRT.
- intervention Names
- Radiation: Stereotactic body radiotherapy
- label
- Malignant Tumors
- type
- OTHER
- interventions
- arm Group Labels
- Benign Tumors
- description
- 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)
- name
- stereotactic body radiotherapy
- type
- RADIATION
- arm Group Labels
- Malignant Tumors
- description
- 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
- name
- Stereotactic body radiotherapy
- type
- RADIATION
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 19
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Complete or partial tumor response or stable disease
- measure
- Local Control Rate
- time Frame
- 5 years
- description
- Instances of progressive disease
- measure
- Local Recurrence
- time Frame
- 5 years
- description
- Number of participants with any adverse event
- measure
- Complication Rate
- time Frame
- 5 years
- secondary Outcomes
- description
- Number of participants who are alive 5 years following treatment.
- measure
- Overall Survival
- time Frame
- 5 years
Full study description
- brief Summary
- 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.
- detailed Description
- 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-95763de3483ee07d2b87
- requested nct id
- NCT01344356
- primary nct id
- NCT01344356
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 38e97f6c23d7b292911d062dea3fc0dffbdcbde03aae232fe8d067fdd28034c9
- payload sha256
- 62e63c9043164d598ae6ebf198986469d3bfcc27af75953c6b62e97c7551f584
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-95763de3483ee07d2b87
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT01344356
- occurrences
- context exact
- NCT01344356
- end
- 11
- exact text
- NCT01344356
- 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/36/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 9cddda4d588a8aedd9ff8e2a20bee885a47e9cb69fd60402de6feaa90ff3575f
Preserved source evidence · Not medical advice