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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Small-cell Lung Cancer

Intervention / Treatment
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* Radiation: SIB-IMRT
* Radiation: routine IMRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Limited-stage small-cell lung cancer, radiotherapy, simultaneous integrated boost