NCT02113423

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1996

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

13.4 years

First QC Date

April 8, 2014

Last Update Submit

April 10, 2014

Conditions

Nasopharyngeal Cancer Recurrent

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    thirteen years

Study Arms (1)

recurrent T1-2 NPC,no treatment

EXPERIMENTAL

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

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

Interventions

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

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

recurrent T1-2 NPC,no treatment

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • recurrent T1-2 nasopharyngeal carcinoma patients

You may not qualify if:

  • non recurrent T1-2 nasopharyngeal carcinoma patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Cancer Hospital Radiation Oncology Department

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Interventions

Radiotherapy, ConformalRadiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Jianji Pan, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 14, 2014

Study Start

January 1, 1996

Primary Completion

June 1, 2009

Study Completion

March 1, 2011

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

CN(1)