Head and Neck Cancer
Conditions
Brief summary
RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment. PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
Detailed description
OBJECTIVES: * Determine the undertaken oxygen sensitive MRI for the detection of hypoxia in patients with Stage III-IV head and neck cancer. * Correlate MRI parameters with histology, gene expression, and plasma osteopontin. * Correlate tumor hypoxia measurements with patient prognosis and treatment response. OUTLINE: * Pre-therapy MRI: Patients undergo blood oxygen level dependant (BOLD) contrast MRI on room air breathing over 2 minutes and with oxygen gas over 15 minutes. Patients also undergo MR-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast MRI with gadolinium contrast over 8 minutes. * Chemoradiotherapy: Patients receive platinum based chemotherapy every two weeks. Patients also undergo radiation therapy for 6 weeks. * Post-radiation MRI: Patients undergo MRI as before chemoradiotherapy. Blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response. After completion of study, patients are followed every 3 months for up to 1 year.
Interventions
External beam radiation to the neck and tumor site of head and neck. Concurrent platinum based chemotherapy. External beam boost at discretion of treating physician.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Stage III or IV disease * Measurable disease * Scheduled to undergo standard treatment including radiation therapy and chemotherapy * Participation on study # 092004-010 for tissue procurement PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Serum creatinine ≤ 1.5 OR creatinine clearance ≥ 40 * Body mass index ≤ 34 Kg/m\^2 * Not claustrophobic * No other contraindications to MRI (i.e., implanted pacemaker device) * Not pregnant or nursing * Negative pregnancy test * No allergy to gadolinium PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor shrinkage and blood oxygen association | 12 weeks | Association between tumor shrinkage and blood oxygen level dependent |
| MRI signal sensitivity to oxygen | 12 weeks | MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate tumor hypoxia with patient prognosis and treatment response | 12 weeks | Association between tumor hypoxia, patient prognosis, and treatment response. |
Countries
United States
Outcome results
None listed