NCT04387266

Brief Summary

This is a retrospective real-world study to evaluate the efficacy and feasibility of modified reduce-volume target IMRT in the treatment of patients with non-metastatic NPC

Trial Health

87
On Track

Trial Health Score

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

Enrollment
471

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

May 10, 2020

Last Update Submit

October 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Local failure-free survival (LFFS)

    The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure.

    60 month

Study Arms (1)

Modified reduce-volume target IMRT

Patients with newly diagnosed, non-metastatic NPC was given modified reduce-volume target IMRT

Radiation: modified reduce-volume target IMRT

Interventions

The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively.

Modified reduce-volume target IMRT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Non-metastatic NPC patients treated with modified reduce-volume target IMRT in our institution

You may qualify if:

  • Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
  • Newly diagnosed, non-metastatic and treated with modified reduce-volume IMRT;
  • Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
  • Diagnosis time: November 1, 2014 to December 31 , 2017

You may not qualify if:

  • Disease progression during IMRT;
  • Previous malignancy or other concomitant malignant diseases;
  • The evaluation information of tumor efficacy can not be obtained;
  • Receive blind treatment in other clinical research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of radiation oncology, Fujian cancer hospital

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2020

First Posted

May 13, 2020

Study Start

June 1, 2020

Primary Completion

August 1, 2020

Study Completion

October 1, 2020

Last Updated

October 9, 2020

Record last verified: 2020-10

Locations