NCT06136962

Brief Summary

Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients.This is an observational study that is being done to evaluate the long-term efficacy, learn about the toxicity and quality of life that survivors of nasopharyngeal carcinoma may have following treated with reduced volume intensity modulated radiation therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 5, 2023

Last Update Submit

November 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival is calculated from diagnosis to death from any cause

    10 years

Secondary Outcomes (6)

  • Loco-regional failure-free survival

    10 years

  • Failure-free survival

    10 years

  • Distant failure-free survival

    10 years

  • Quality of Life Questionnaires QLQ-C30

    1year

  • Quality of Life Questionnaires

    1year

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Histologically diagnosed non-metastatic Nasopharyngeal carcinoma (NPC) patients who were treated with Reduced Volume Intensity Modulated Radiation Therapy.

You may qualify if:

  • Received treatment with Reduced Volume Intensity Modulated Radiation Therapy
  • Age 18 or above, upper limit 65
  • Ability to comply with the protocol

You may not qualify if:

  • History of recurrent nasopharyngeal disease
  • A history of any physical, psychological or social condition which would impair with the ability of the patient to cooperate in this study
  • Unable to provide consent

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

Central Study Contacts

Lin Shaojun, MD

CONTACT

Qiaojuan Guo, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 5, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations