Small-cell Lung Cancer
Conditions
Keywords
Limited-stage small-cell lung cancer, radiotherapy, simultaneous integrated boost
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.
Interventions
RADIATIONSIB-IMRT
60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time
RADIATIONroutine IMRT
patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress-free survival | 2 year | the rate of patients survival from the treatment to death or progress |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary Contactzongmei zhou, Professor
Backup Contactlei deng, Dr
Outcome results
None listed