Nasopharyngeal Carcinoma Treated With Reduced Volume Inte... | NCT06136962

Studies
Nasopharyngeal Carcinoma Treated With Reduced Volume Intensity Modulated Radiation Therapy:10-Year Outcome and Late Toxicity, Quality of Life

NCT06136962

Sponsor

Fujian Cancer Hospital

Status

Unknown status

Last Update Posted

Nov 18, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Nasopharyngeal Carcinoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Nov 5, 2023

First Submission Date that Met QC Criteria

Nov 16, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival is calculated from diagnosis to death from any cause	10 years

Secondary Outcomes

Measure	Description	Time Frame
Loco-regional failure-free survival	Loco-regional failure-free survival is calculated from diagnosis to the first loco-regional failure	10 years
Failure-free survival	Failure-free survival rate is calculated from the date of diagnosis to the date of treatment failure or death from any cause, whichever is first

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Shaojun, MD	Contact	13860603879		linshaojun@yeah.net
Qiaojuan Guo, MD	Contact	15080013157		guoqiaojuan@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of radiation oncology, Fujian cancer hospital		Fuzhou	Fujian	350014	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided