Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients

NCT03411954 | Unknown

• 1 other identifier: NPC-2017-209
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

hippocampus avoidance; cognitive changes; intensity modulated radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• cognitive function changes

  1 year

• memory function changes

  1 year

• quality of life

  1 year

Study Arms (1)

HP-RT

Hippocampus avoidance: decrease the dose to hippocampus as low as possible without affecting the target volumes and other normal tissues

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• yuanyaun chen, professor

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuanyuan chen, professor

CONTACT

+86 13738103808; chenyy@zjcc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: January 26, 2018
• Study Start: January 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2022
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)