Trials / Completed
CompletedNCT01344356
Stereotactic Body Radiotherapy for Head and Neck Tumors
Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Mercy Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Nasopharyngeal Carcinoma
- Salivary Gland Cancer
- Head and Neck Sarcoma
- Paraganglioma of Head and Neck
- Chordoma of Head and Neck
- Chondrosarcoma of Head and Neck
- Angiofibroma of Head and Neck
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | stereotactic body radiotherapy | 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) |
| RADIATION | Stereotactic body radiotherapy | 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) |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2018-05-01
- Completion
- 2018-05-01
- First posted
- 2011-04-29
- Last updated
- 2020-04-10
- Results posted
- 2020-04-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01344356. Inclusion in this directory is not an endorsement.