Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma

Nasopharyngeal Cancer Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113423
• Other study ID #: FJCH009911
• Status: Completed
• Phase: N/A
• First received: April 8, 2014
• Last updated: April 10, 2014
• Start date: January 1996
• Est. completion date: March 2011

Study information

• Verified date: April 2014
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• recurrent T1-2 nasopharyngeal carcinoma patients

Exclusion Criteria:

• non recurrent T1-2 nasopharyngeal carcinoma patients

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Cancer Recurrent
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
China	Fujian Cancer Hospital Radiation Oncology Department	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		thirteen years	No