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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Small-cell Lung Cancer

Treatments: Radiation: SIB-IMRT; Radiation: routine IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT04500145

CH-L-072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

SIB-IMRT

Active Comparator group

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.

Treatment:

Radiation: SIB-IMRT

routine

Other group

Description:

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

Treatment:

Radiation: routine IMRT