Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients

NCT ID: NCT03411954

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-03-31

Brief Summary

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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

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HP-RT

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

No interventions assigned to this group

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yuanyaun chen, professor

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yuanyuan chen, professor

Role: CONTACT

+86 13738103808

Facility Contacts

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yuanyuan chen, Professor

Role: primary

+86 13738103808

Other Identifiers

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NPC-2017-209

Identifier Type: -

Identifier Source: org_study_id

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