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

January 27, 2021 updated by: Zongmei Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Randomized Phase III Study of Comparison Between Simultaneous Integrated Boost (SIB) Intensity-modulated Radiation Therapy (IMRT) Versus Routine IMRT/VMAT in LD-SCLC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: SIB-IMRT
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
60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time
OTHER: routine
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
patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 year
rate of patients survival in 2 years
2 year
local control rate
Time Frame: 2 year
recurrence rate of local field in 2 years
2 year
side-effects
Time Frame: 3-6months after radiation
the rate of radiation pneumatic、oesophagitis、haematological toxicity
3-6months after radiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: zongmei zhou, PhD, National Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 20, 2017

Primary Completion (ANTICIPATED)

July 20, 2021

Study Completion (ANTICIPATED)

October 20, 2021

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (ACTUAL)

August 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-L-072

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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