TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients

NCT ID: NCT03588403

Last Updated: 2018-07-20

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

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2022-07-31

Brief Summary

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Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm A:Tomotherapy

Patients with non-disseminated nasopharyngeal carcinoma receiving Tomotherapy.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F.

TOMO

Intervention Type RADIATION

Tomotherapy

Arm B: IMRT

Patients with non-disseminated nasopharyngeal carcinoma receiving IMRT.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F.

IMRT

Intervention Type RADIATION

Intensity modulated radiotherapy

Interventions

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TOMO

Tomotherapy

Intervention Type RADIATION

IMRT

Intensity modulated radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Tumor staged T1-4N0-3M0 (according to the 8th AJCC staging system)
3. Performance status: KPS\>70
4. With normal liver function test (ALT, AST \<1.5ULN)
5. Renal: creatinine clearance \>60ml/min
6. Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
7. Written informed consent

Exclusion Criteria

1. WHO type I squamous cell carcinoma or adenocarcinoma
2. Age \>65 or \<18
3. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
4. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
5. Patient is pregnant or lactating
6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Chen Xiaozhong

chief phisician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xiaozhong Chen

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiaozhong Chen, MD

Role: primary

+86-571-88128202

Other Identifiers

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IRB-2018-133

Identifier Type: -

Identifier Source: org_study_id

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