Comparing two types of radiation therapy for 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)
This study is testing which type of radiation therapy works better for people with recurrent head and neck cancer who have already had radiation treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03164460 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of stereotactic body radiation therapy versus intensity modulated radiation/proton therapy in patients with recurrent head and neck cancer. The study aims to assess the rate of severe toxicity and compare locoregional failure-free survival between the two treatment approaches. Patients will be monitored for local control, progression-free survival, and overall survival, as well as for various patient-reported outcomes related to symptoms and quality of life. The trial includes patients who have previously received radiation and have measurable disease.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed recurrent head and neck cancer who have previously received radiation and are not surgical candidates.
Not a fit: Patients with widely metastatic disease or significant uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and less toxic treatment option for patients with recurrent head and neck cancer.
How similar studies have performed: Other studies have shown promise with similar radiation therapy approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jack Phan — M.D. Anderson Cancer Center
- Study coordinator: Jack Phan, MD, PHD
- Email: jphan@mdanderson.org
- Phone: 713-563-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.