UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000055584
Receipt number R000063519
Scientific Title The impact of EGFR mutations on outcomes after chemoradiotherapy for locally advanced non small cell lung cancer: a systematic review and meta-analysis
Date of disclosure of the study information 2024/09/24
Last modified on 2024/09/22 17:56:43

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Basic information

Public title

The outcome of chemoradiotherapy for NSCLC - EGFR mutant vs wild-type -

Acronym

The outcome of chemoradiotherapy for NSCLC - EGFR mutant vs wild-type -

Scientific Title

The impact of EGFR mutations on outcomes after chemoradiotherapy for locally advanced non small cell lung cancer: a systematic review and meta-analysis

Scientific Title:Acronym

The impact of EGFR mutations on outcomes after CRT for LA-NSCLC: a systematic review and meta-analysis

Region

Japan


Condition

Condition

non small cell lung cancer

Classification by specialty

Pneumology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the influence of EGFR mutations on survival outcomes in patients with locally advanced non small cell lung cancer treated with chemoradiotherapy

Basic objectives2

Others

Basic objectives -Others

The difference of survival outcomes after chemoradiotherapy for locally advanced non-small cell lung cancer

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

progression-free survival and overall survival

Key secondary outcomes

post-progression survival, patterns of disease progression


Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria were: (i) studies reporting survival outcomes following CRT for LA-NSCLC; (ii) studies comparing survival outcomes between EGFR mutant

Key exclusion criteria

Exclusion criteria were: (i) non-English publications; (ii) studies including patients receiving targeted therapy or immunotherapy; (iii) studies involving radiotherapy alone.

Target sample size



Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Ochiai

Organization

JAPANESE RED CROSS ISE HOSPITAL

Division name

Department of Radiation Oncology

Zip code

516-8512

Address

Ise Red Cross Hospital 1-471-2 Funae, Ise City, Mie Prefecture, Japan

TEL

0596-28-2171

Email

sochiamn@gmail.com


Public contact

Name of contact person

1st name Satoru
Middle name
Last name Ochiai

Organization

JAPANESE RED CROSS ISE HOSPITAL

Division name

Department of Radiation Oncology

Zip code

516-8512

Address

Ise Red Cross Hospital 1-471-2 Funae, Ise City, Mie Prefecture, Japan

TEL

0596-28-2171

Homepage URL


Email

sochiamn@gmail.com


Sponsor or person

Institute

JAPANESE RED CROSS ISE HOSPITAL, Department of Radiation Oncology, Satoru Ochiai

Institute

Department

Personal name



Funding Source

Organization

JAPANESE RED CROSS ISE HOSPITAL, Department of Radiation Oncology, Satoru Ochiai

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

JAPANESE RED CROSS ISE HOSPITAL, Department of Radiation Oncology, Satoru Ochiai

Address

1-471-2 Funae, Ise City, Mie Prefecture, Japan

Tel

0596-28-2171

Email

sochiamn@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2024 Year 09 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2024 Year 09 Month 20 Day

Date of IRB


Anticipated trial start date

2024 Year 10 Month 01 Day

Last follow-up date

2024 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will conduct a systematic review to identify studies evaluating survival outcomes after CRT for locally advanced non-small cell lung cancer, comparing EGFR mutant and wild-type using Kaplan-Meier curves.
In the literature search, we will search through PubMed, EMBASE, and Web of Science.
The search keywords includes "chemoradiotherapy OR chemoradiation" AND "lung" AND "epidermal growth factor OR EGFR"
We plan to include studies reported up to September 2024.


Management information

Registered date

2024 Year 09 Month 22 Day

Last modified on

2024 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063519