SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC

Study Overview
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Brief Summary
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As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung cancer

Official Title
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Stereotactic Body Radiation Therapy Compared With Intensity Modulated Radiation Therapy Concurrently With Chemotherapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: SBRT
* Radiation: IMRT
* Drug: EP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic diagnosis of SCLC limited-stage disease is defined as disease confined to the ipsilateral hemithorax, which can be safely encompassed within a radiation field No prior chemotherapy, or radiotherapy Performance status of 0, 1, 2 on the ECOG criteria. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000). Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment. Exclusion Criteria: Non small cell lung cancer and carcinoid Supraclavicular lymphadenopathy Inability to comply with protocol or study procedures. Moderate and severe ventilation dysfunction Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. Pregnant or breast-feeding. Enrollment in other study within 30 days

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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No

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 |
| --- | --- |
| Experimental: GROUP 1<br>SBRT plus EP | Radiation: SBRT<br>* 40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.<br>Drug: EP<br>* Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.<br>|
| Active Comparator: GROUP 2<br>IMRT plus EP | Radiation: IMRT<br>* 45 Gy for each patient，Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks.<br>Drug: EP<br>* Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | the first date of treatment to 3 months after the last dose of study drug | 
| Tumor response rate |  | the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years | 

 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, Stereotactic body radiation therapy, Intensity modulated radiation therapy, Radiation, Chemotherapy