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Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Cancer Recurrent

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT

About this trial

This is an interventional treatment trial for Nasopharyngeal Cancer Recurrent focused on measuring superiority, re-irradiation, IMRT, recurrent T1-2 NPC

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

recurrent T1-2 nasopharyngeal carcinoma patients

Exclusion Criteria:

non recurrent T1-2 nasopharyngeal carcinoma patients

Sites / Locations

Fujian Cancer Hospital Radiation Oncology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

recurrent T1-2 NPC,no treatment

Arm Description

3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT02113423

First Posted

April 8, 2014

Last Updated

April 10, 2014

Sponsor

Fujian Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02113423

Brief Title

Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma

Official Title

Superiority of Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 1996 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fujian Cancer Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Cancer Recurrent

Keywords

superiority, re-irradiation, IMRT, recurrent T1-2 NPC

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

recurrent T1-2 NPC,no treatment

Arm Type

Experimental

Arm Description

3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT

Intervention Type

Radiation

Intervention Name(s)

3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT

Intervention Description

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

Primary Outcome Measure Information:

Title

all cause mortality

Time Frame

thirteen years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: recurrent T1-2 nasopharyngeal carcinoma patients Exclusion Criteria: non recurrent T1-2 nasopharyngeal carcinoma patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianji Pan, MD

Organizational Affiliation

Department of Radiation Oncology, Cancer Hospital of Fujian Medical University, Fuzhou, Fujian, People's Republic of China

Official's Role

Study Director

Facility Information:

Facility Name

Fujian Cancer Hospital Radiation Oncology Department

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350014

Country

China

12. IPD Sharing Statement

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Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma

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