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TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT03588403
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Chen Xiaozhong, Zhejiang Cancer Hospital

Brief Summary:
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

Condition or disease Intervention/treatment
Nasopharyngeal Carcinoma Radiation: TOMO Radiation: IMRT

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Radiation: TOMO
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.
Radiation: IMRT
Intensity modulated radiotherapy




Primary Outcome Measures :
  1. QoL(quality of life) [ Time Frame: 2 years ]
    Changes in quality of life were assessed by EORTC QLQ-C30


Secondary Outcome Measures :
  1. PFS (progression free survival) [ Time Frame: 2 years ]
    from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ).

  2. OS (overall survival) [ Time Frame: 2 years ]
    from the first day of therapy to death or last follow-up

  3. LRRFS(Locoregional failure-free survival) [ Time Frame: 2 years ]
    from the first day of therapy to the date of first locoregional relapse or until the date of the last follow-up visit.

  4. Adverse Events [ Time Frame: 5 years ]
    Participants will be followed for the duration of hospital stay, an expected average of 50 days and every 3 months thereafter for 5 years. Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE 4.03 during the chemoradiation and follow-up.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
nasopharyngeal carcinoma patients staged T1-4N0-3M0
Criteria

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.


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): NCT03588403


Locations
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China, Zhejiang
Xiaozhong Chen Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaozhong Chen, MD    +86-571-88128202    cxzfyun@sina.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital

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Responsible Party: Chen Xiaozhong, chief phisician, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03588403     History of Changes
Other Study ID Numbers: IRB-2018-133
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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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
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases