Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT03411954
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-01
• Study First Submitted: 2018-01-13
• Study First Submitted QC: 2018-01-19
• Last Update Submitted: 2018-01-19
• Study First Posted: 2018-01-26
• Last Update Posted: 2018-01-26
• Primary Completion: 2021-02
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Histologically or cytologic confirmed nasopharyngeal carcinoma
2. ECOG performance scale 0-2
3. Tumor stage is T4N0-3M0-1 according to 8th American Joint Commission on Cancer edition
4. 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.
5. Informed consent signed.

Exclusion Criteria

1. History of malignant tumors.
2. Any severe complications contraindicated chemotherapy or radiotherapy.
3. Medical history of central nervous system, cognitive or psychological diseases;
4. Pregnant or nursing women.
5. Patients with mental disease cannot complete the questionaire.
6. MRI contraindication -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the dose-volume relationship between hippocampus and cognitive function	1 year	To explore the relationship between cognitive impairment and exposure dose of hippocampus in patients with nasopharyngeal carcinoma.

Secondary Outcome Measures

Name	Time	Method
cognitive function changes	1 year	response to the Montreal Cognitive Assessment
memory function changes	1 year	response to the Hopkins Verbal Learning Test
quality of life	1 year	response to the QLQ-C30

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China