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

Primary Purpose

Small-cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SIB-IMRT
routine IMRT
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring Limited-stage small-cell lung cancer, radiotherapy, simultaneous integrated boost

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

SIB-IMRT

routine

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

overall survival
rate of patients survival in 2 years
local control rate
recurrence rate of local field in 2 years
side-effects
the rate of radiation pneumatic、oesophagitis、haematological toxicity

Full Information

First Posted
August 3, 2020
Last Updated
January 27, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04500145
Brief Title
Simultaneous Integrated Boost vs. Routine IMRT in Limited-stage Small-cell Lung Cancer
Official Title
A Randomized Phase III Study of Comparison Between Simultaneous Integrated Boost (SIB) Intensity-modulated Radiation Therapy (IMRT) Versus Routine IMRT/VMAT in LD-SCLC
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
October 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer
Keywords
Limited-stage small-cell lung cancer, radiotherapy, simultaneous integrated boost

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIB-IMRT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
routine
Arm Type
Other
Arm Description
patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy
Intervention Type
Radiation
Intervention Name(s)
SIB-IMRT
Intervention Description
60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time
Intervention Type
Radiation
Intervention Name(s)
routine IMRT
Intervention Description
patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy
Primary Outcome Measure Information:
Title
progress-free survival
Description
the rate of patients survival from the treatment to death or progress
Time Frame
2 year
Secondary Outcome Measure Information:
Title
overall survival
Description
rate of patients survival in 2 years
Time Frame
2 year
Title
local control rate
Description
recurrence rate of local field in 2 years
Time Frame
2 year
Title
side-effects
Description
the rate of radiation pneumatic、oesophagitis、haematological toxicity
Time Frame
3-6months after radiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zongmei zhou, Professor
Phone
86 13801389769
Email
zhouzongmei2013@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
lei deng, Dr
Phone
86 13683377570
Email
dengleipumc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zongmei zhou, PhD
Organizational Affiliation
national cancer hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zongmei zhou, professor
Phone
86 13801389769
Email
zhouzongmei2013@163.com

12. IPD Sharing Statement

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

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