Clinical trial NCT04500145: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Small-cell Lung Cancer
Keywords: Limited-stage small-cell lung cancer
radiotherapy
simultaneous integrated boost
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-08-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progress-free survival
timeFrame: 2 year
Secondary outcomes:
measure: overall survival
timeFrame: 2 year
measure: local control rate
timeFrame: 2 year
measure: side-effects
timeFrame: 3-6months after radiation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: national cancer hospital
name: zongmei zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References: