Clinical trial · Interventional
Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer
Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation Versus Conventionally Fractionated Conformal Radiotherapy for Patients With Small Inoperable Head and Neck Tumors (SOAR-HN)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Request
Summary
Brief summary (as posted)
This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.
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 |
|---|---|---|---|
| Recurrent Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Proton Radiation | Radiation | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (SBRT)
- description
- Patients undergo SBRT every other day for a total of 5 treatments.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- Group II (IMRT/IMPT)
- description
- Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy
- Radiation: Proton Radiation
Primary outcomes (1)
- measure
- Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer * Not eligible for surgery for recurrence or poor surgical candidate * Gross disease apparent on imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) * 1-3 sites of recurrence (\< 60 cc per site, total volume \< 100 cc) * Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2 * Negative pregnancy test for women of child bearing potential Exclusion Criteria: * Patients who are pregnant or breast feeding * Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: * a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device * b) No myocardial infarction within 3 months of registration * Widely metastatic disease (oligometastatic disease acceptable)
References
Publications (0)
Data not yet available