Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer
Phase I Dose Escalation Study of Stereotactic Body Radiotherapy for Carcinoma of the Head and Neck in High Risk Patients Who Are Ineligible/Refuse Standard of Care Therapy
NCT02388932CI-TRIAL-00036725terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy (SBRT) in treating participants with head and neck cancer that has spread from where it started to nearby tissue or lymph nodes and is at high risk for continuing to spread because the participant cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a specialized radiation therapy that delivers radiation directly to the tumor in smaller doses over several days, which may kill more tumor cells and cause less damage to normal tissue.
Conditions
Conditions (28)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Hypopharyngeal Squamous Cell Carcinoma | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Laryngeal Squamous Cell Carcinoma | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma | Sinonasal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Nasopharyngeal Keratinizing Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Oral Cavity Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Device | — | UNRESOLVED |
| Positron Emission Tomography | Device | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SBRT)
- description
- Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- Device: Positron Emission Tomography
- Device: Computed Tomography
- Other: Quality-of-Life Assessment
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of Head and Neck SBRT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The participant must have squamous cell carcinoma proven by histologic diagnosis; for cancers of the oropharynx, p16 staining by immunohistochemistry must be negative; for cancers of the larynx, hypopharynx, oral cavity, nasopharynx, paranasal sinuses, p16 staining is not required * The participant must have clinical stage T1-4, N0-3, M0-1, stage II-IVC carcinoma as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging manual; participants with T1N0M0 will be ineligible; participants with metastatic disease with a limited metastatic burden are eligible if obtaining local control is determined by their treating oncologist to be an important therapeutic goal * The participant must have imaging documenting a primary tumor, or involved lymph node, ≥ 2.5 cm in greatest dimension * PET/CT is required for all participants, unless contraindicated; this may be acquired prior to study entry or after enrollment prior to SBRT planning * The participant must have a history and physical documented within four weeks of registration and be deemed by a medical oncologist to be ineligible for standard continuous course chemoradiotherapy with cisplatin * Karnofsky performance status (PS) ≥ 40 * Female participants cannot be of childbearing age, or if they are, must have a negative pregnancy test prior to enrollment and be willing to use contraceptives during treatment and continue for 6 additional months * Participants must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants with T1N0M0 stage I disease * Participants who are receiving any other investigational agents * Participants with non-squamous cell histology * Participants with life expectancy \< 6 months * Participants who cannot lie flat for 20 minutes * Participants with prior history of head and neck radiotherapy (\> 40 Gy) with significant areas of anticipated overlap
References
Publications (0)
Data not yet available
No reference posted for this study.