Simultaneous Integrated Boost vs. Routine IMRT in Limited... | NCT04500145

Studies
Simultaneous Integrated Boost vs. Routine IMRT in Limited-stage Small-cell Lung Cancer

NCT04500145

Sponsor

Chinese Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Feb 1, 2021Actual

Enrollment

350Estimated

Phase

Phase 3

Conditions

Small-cell Lung Cancer

Interventions

SIB-IMRT
routine IMRT

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2017Actual

Primary Completion Date

Jul 20, 2021Estimated

Completion Date

Oct 20, 2021Estimated

First Submitted Date

Aug 3, 2020

First Submission Date that Met QC Criteria

Aug 3, 2020

First Posted Date

Aug 5, 2020Actual

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 27, 2021

Last Update Posted Date

Feb 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zongmei Zhou, Clinical Professor, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Thoracic radiotherapy concurrent with chemotherapy stands for the standard regime for limited staged small cell lung cancer. Involved node radiation（INF） replaced elective node irradiation（ENI） as the more popular since several trails compared the two regimes. simultaneous integrated boost IMRT becomes mature with advancing in IMRT and VMAT. The investigator hypothesis that SIB-IMRT can confine the dose for organs at risk to reduce the toxicities compared with routine IMRT in limited disease small-cell lung cancer.

Detailed Description

All patients recruited divided into two arms：SIB-IMRT or routine IMRT，in the routine arm，the prescription dose was 60Gy/2Gy/30f，and in the SIB arm ，60Gy was given to the field of the tumor and metastatic lymph nodes，50Gy was given to CR lesion and high-risk prevention. The physical advantages of SIB-IMRT are to reduce the radiation dose of organs that are at risk in the lungs, esophagus, and heart ensuring the adequate dose for tumor area at the same time. The investigators are carrying out this trial to compare the efficacy, safety, side effects, and type of failure of the two radiotherapy techniques, which will provide a new choice and reliable basis for the future dose-segmentation study of limited-stage small-cell lung cancer.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SIB-IMRT	Active Comparator	patients received radiotherapy using IMRT or VMAT，60Gy is given to the field of tumor and metastatic lymph nodes and 50Gy given to CR lesion and high-risk area.concurrent or sequential with 4-6 circles of chemotherapy of EP.	Radiation: SIB-IMRT
routine	Other	patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy	Radiation: routine IMRT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SIB-IMRT	Radiation	60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time	SIB-IMRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progress-free survival	the rate of patients survival from the treatment to death or progress	2 year

Secondary Outcomes

Measure	Description	Time Frame
overall survival	rate of patients survival in 2 years	2 year
local control rate	recurrence rate of local field in 2 years	2 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-70 years old,KPS≥80
pathological small cell lung cancer
staged as limited disease SCLC（contralateral hilar invasion not included）
receive radiotherapy concurrent or sequential with chemotherapy，if induction chemotherapy，got PR or SD
no other tumors
No serious medical diseases and dysfunction of major organs
understand this study，able to complete the treatment，accept the following up and sign the informed consent
Contraception in women of childbearing age.

Exclusion Criteria:

other malignant tumor（historically or simultaneously）curable non-melanoma skin cancer and cervical carcinoma in situ not included
Uncontrolled heart disease or myocardial infarction within 6 months
History of mental illness
Pregnancy or Lactation
uncontrolled diabetes、hypertension

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
zongmei zhou, Professor	Contact	86 13801389769		zhouzongmei2013@163.com
lei deng, Dr	Contact	86 13683377570		dengleipumc@163.com

Overall Officials

Name	Affiliation	Role
zongmei zhou, PhD	national cancer hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences	Recruiting	Beijing	Beijing Municipality	100021	China

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

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

Browse Leaves

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Browse Branches

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