- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02113423
Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma
Superiority of Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma
The hypothesis of the study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC.
Characters of the patients:
- list item one: 168 patients, median age 48 years (range 16-75 years) proven rT1-2 NPC were diagnosed
- list item two: Treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or IMRT).
- list item three: Median time to recurrence was 30 months (range 1-180months). The median follow-up time was 28 months (range, 4-135 months).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives:
Recurrent T1-2 Nasopharyngeal Carcinoma (rT1-2) may be salvaged by 3D - CRT(3D-Conformal Radiotherapy), IMRT( Intensity Modulated Radiotherapy), Brachytherapy (BT), BT combined 3D - CRT or IMRT . The aim of this study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC.
Methods and Materials:
168 patients, median age 48 years (range 16-75 years) proven rT1-2 NPC were diagnosed and treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or IMRT) . Median time to recurrence was 30 months (range 1-180months). The median follow-up time was 28 months (range, 4-135 months).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350014
- Fujian Cancer Hospital Radiation Oncology Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- recurrent T1-2 nasopharyngeal carcinoma patients
Exclusion Criteria:
- non recurrent T1-2 nasopharyngeal carcinoma patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: recurrent T1-2 NPC,no treatment
3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT
|
3D - CRT(3D-Conformal Radiotherapy): CTV-P 50-60Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) IMRT(Intensity Modulated Radiotherapy): GTV-P 50-60 Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) BT(Brachytherapy): 2.5Gy BID*10F one week interval BT combined 3D - CRT or IMRT: First,GTV-P 40Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week);Then, 2.5Gy BID*2F
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause mortality
Time Frame: thirteen years
|
thirteen years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jianji Pan, MD, Department of Radiation Oncology, Cancer Hospital of Fujian Medical University, Fuzhou, Fujian, People's Republic of China
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Recurrence
Other Study ID Numbers
- FJCH009911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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