Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03411954
• Other study ID #: NPC-2017-209
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2018
• Last updated: January 19, 2018
• Start date: January 1, 2018
• Est. completion date: March 2022

Study information

• Verified date: January 2018
• Source: Zhejiang Cancer Hospital
• Contact: yuanyuan chen, professor
• Phone: +86 13738103808
• Email: chenyy[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2022
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cognitive function changes	response to the Montreal Cognitive Assessment	1 year
Secondary	memory function changes	response to the Hopkins Verbal Learning Test	1 year
Secondary	quality of life	response to the QLQ-C30	1 year