Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients

Study Overview
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Brief Summary
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This is a prospective, non-randomized phase III study observing the cognitive function changes with conformal hippocampus avoidance during intensity modulated radiotherapy for T4 nasopharyngeal carcinoma patients.

Detailed Description
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All patients received intensity modulated radiotherapy or Tomotherapy with or without chemotherapy. Before radiotherapy, the patients will receive brain MRI scanning and the brain MRI images will be fused with the head and neck CT scan images. The investigators develop the treatment plan with hippocampus avoidance. Cognitive function are evaluated before,during and after radiotherapy. Dose-volume Histograms are got to analyze the associated factors.

Official Title
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Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients:an Open, Prospective,Non-randomized Phase III Clinical Trial

Conditions
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Nasopharyngeal Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologic confirmed nasopharyngeal carcinoma ECOG performance scale 0-2 Tumor stage is T4N0-3M0-1 according to 8th American Joint Commission on Cancer edition Adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 100×10^9/L, neutrophils ≥ 1.5×10^9/L, serum transaminase < 2.5×the upper limit of normal(ULN), (If liver metastases, serum transaminase< 5×the ULN), creatinine clearance rate > 60ml/min. Informed consent signed. Exclusion Criteria: History of malignant tumors. Any severe complications contraindicated chemotherapy or radiotherapy. Medical history of central nervous system, cognitive or psychological diseases; Pregnant or nursing women. Patients with mental disease cannot complete the questionaire. MRI contraindication -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HP-RT<br>Hippocampus avoidance: decrease the dose to hippocampus as low as possible without affecting the target volumes and other normal tissues | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the dose-volume relationship between hippocampus and cognitive function | To explore the relationship between cognitive impairment and exposure dose of hippocampus in patients with nasopharyngeal carcinoma. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function changes | response to the Montreal Cognitive Assessment | 1 year | 
| memory function changes | response to the Hopkins Verbal Learning Test | 1 year | 
| quality of life | response to the QLQ-C30 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hippocampus avoidance, cognitive changes, intensity modulated radiotherapy