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

Phase 3

• Conditions: Small-cell Lung Cancer
• Interventions: Radiation: routine IMRT; Radiation: SIB-IMRT

• Registration Number: NCT04500145
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2017-07-20
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-05
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01
• Primary Completion: 2021-07-20
• Study Completion: 2021-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
routine	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
SIB-IMRT	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.

Primary Outcome Measures

Name	Time	Method
progress-free survival	2 year	the rate of patients survival from the treatment to death or progress

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China