Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma

NCT ID: NCT02113423

Last Updated: 2014-04-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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).

Conditions

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Nasopharyngeal Cancer Recurrent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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recurrent T1-2 NPC,no treatment

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

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

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

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* recurrent T1-2 nasopharyngeal carcinoma patients

Exclusion Criteria

* non recurrent T1-2 nasopharyngeal carcinoma patients
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianji Pan, MD

Role: STUDY_DIRECTOR

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

Locations

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Fujian Cancer Hospital Radiation Oncology Department

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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FJCH009911

Identifier Type: -

Identifier Source: org_study_id

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