Clinical trial · Interventional
Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
NCT02110992CI-TRIAL-00041907terminatedPhase 1ClinicalTrials.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)
The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Stereotactic Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel + Stereotactic Radiation
- description
- Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by \> 48 hours.
- interventionNames
- Drug: Docetaxel
- Radiation: Stereotactic Radiation
Primary outcomes (1)
- measure
- Number of acute dose limiting toxicities
- timeFrame
- 3 months
- description
- Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture
Secondary outcomes (4)
- measure
- Locoregional control
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent or second primary squamous cell head and neck cancer * Defined area of recurrence on imaging * Previous head and neck radiation (RT) to \>/= 50 Gy * Performance status score 0-1 * Time interval from previous RT \>/= 9 months * Volume of disease appropriate for protocol treatment * Minimum estimated survival of \>/= 3 months * Age \>/= 18 * Adequate labs Exclusion Criteria: * Primary tumors of the salivary gland * Original pathology report and radiation therapy records not available * Prior spinal cord dose \> 45 Gy * Surgery or chemotherapy within 4 weeks * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted
References
Publications (0)
Data not yet available
No reference posted for this study.