NCT04500145

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.

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
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2017

Typical duration for phase_3

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

Study Start

First participant enrolled

July 20, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

August 3, 2020

Last Update Submit

January 27, 2021

Conditions

Small-cell Lung Cancer

Keywords

Limited-stage small-cell lung cancerradiotherapysimultaneous integrated boost

Outcome Measures

Primary Outcomes (1)

  • progress-free survival

    the rate of patients survival from the treatment to death or progress

    2 year

Secondary Outcomes (3)

  • overall survival

    2 year

  • local control rate

    2 year

  • side-effects

    3-6months after radiation

Study Arms (2)

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

SIB-IMRTRADIATION

60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time

SIB-IMRT
routine IMRTRADIATION

patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy

routine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • zongmei zhou, PhD

    national cancer hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zongmei zhou, Professor

CONTACT

86 13801389769zhouzongmei2013@163.com

lei deng, Dr

CONTACT

86 13683377570dengleipumc@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 5, 2020

Study Start

July 20, 2017

Primary Completion

July 20, 2021

Study Completion

October 20, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

CN(1)