Local Radiotherapy for Residual Tumor Lesions During the... | NCT05205226

Studies
Local Radiotherapy for Residual Tumor Lesions During the First-line Treatment

NCT05205226

Sponsor

Hunan Province Tumor Hospital

Status

Completed

Last Update Posted

Jan 25, 2022Actual

Enrollment

636Actual

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2018Actual

Primary Completion Date

Jun 5, 2021Actual

Completion Date

Jan 2, 2022Actual

First Submitted Date

Jan 11, 2022

First Submission Date that Met QC Criteria

Jan 11, 2022

First Posted Date

Jan 25, 2022Actual

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

Jan 11, 2022

Last Update Posted Date

Jan 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yongchang Zhang, Director, Head of Medical Oncology, Principal Investigator, Clinical Professor, Hunan Province Tumor HospitalPrincipal Investigator

Lead Sponsor

Hunan Province Tumor HospitalOTHER

Collaborators

Not provided

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

This study aimed to confirmed that local radiotherapy for residual lesions can significantly prolong the efficacy of chemotherapy combined with immunotherapy in the initial treatment of advanced non-small cell lung cancer.

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

Retention

Enrollment

636Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	Progression free survival time	January 2018 to June 2021

Secondary Outcomes

Measure	Description	Time Frame
RT	radiotherapy control time	January 2018 to June 2021

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18，Advanced Non-small Cell Lung Cancer Confirmed by Histopathology Patients received platinum-based chemotherapy combined with immunotherapy

Exclusion Criteria:

EGFR/ALK/ROS1 driver gene mutation
Chemotherapy only
Concurrent radio-chemotherapy
Surgery
Single-agent immunotherapy
No treatment information available

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with non driver mutation advanced non-small-cell lung cancer non driver mutation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yongchang C Zhang, MD	Hunan Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hunan Cancer Hospital		Changsha	Hunan	410013	China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided