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Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03411954
Recruitment Status : Unknown
Verified January 2018 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Study Description
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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.

Condition or disease
Nasopharyngeal Carcinoma

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients:an Open, Prospective,Non-randomized Phase III Clinical Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2022

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Groups and Cohorts
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Group/Cohort
HP-RT
Hippocampus avoidance: decrease the dose to hippocampus as low as possible without affecting the target volumes and other normal tissues


Outcome Measures
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Primary Outcome Measures :
  1. the dose-volume relationship between hippocampus and cognitive function [ Time Frame: 1 year ]
    To explore the relationship between cognitive impairment and exposure dose of hippocampus in patients with nasopharyngeal carcinoma.


Secondary Outcome Measures :
  1. cognitive function changes [ Time Frame: 1 year ]
    response to the Montreal Cognitive Assessment

  2. memory function changes [ Time Frame: 1 year ]
    response to the Hopkins Verbal Learning Test

  3. quality of life [ Time Frame: 1 year ]
    response to the QLQ-C30


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
100
Criteria

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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411954


Contacts
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Contact: yuanyuan chen, professor +86 13738103808 chenyy@zjcc.org.cn

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: yuanyuan chen, Professor    +86 13738103808    chenyy@zjcc.org.cn   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: yuanyaun chen, professor Zhejiang Cancer Hospital
More Information
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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03411954    
Other Study ID Numbers: NPC-2017-209
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhejiang Cancer Hospital:
hippocampus avoidance
cognitive changes
intensity modulated radiotherapy
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal 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