Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03411954

Enrollment

100

Registered

2018-01-26

Start date

2018-01-01

Completion date

2022-03-31

Last updated

2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

hippocampus avoidance, cognitive changes, intensity modulated radiotherapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary Contactyuanyuan chen, professor

chenyy@zjcc.org.cn+86 13738103808

Outcome results