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Completed

NCT Number: NCT02113423

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).

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Key information

Conditions

Nasopharyngeal Cancer Recurrent

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Cancer Hospital Radiation Oncology Department

Fuzhou, Fujian, 350014, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • recurrent T1-2 nasopharyngeal carcinoma patients

Exclusion criteria

  • non recurrent T1-2 nasopharyngeal carcinoma patients

Treatment and study plan

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

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

Primary outcomes

  1. all cause mortality

    Time frame: thirteen years

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
1996
Primary completion
2009
Study completion
2011
First posted
Apr 14, 2014
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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