Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer

Study Overview
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Brief Summary
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This Phase II randomized study is to determine whether once-daily simultaneous modulated accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for patients with limited-stage small-cell lung cancer (LD-SCLC).

Detailed Description
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This Phase II randomized study is to determine whether once-daily (qd)simultaneous modulated accelerated thoracic radiotherapy resulted in better survival than twice-daily(bid) RT for patients with limited-stage small-cell lung cancer (LD-SCLC). All patients receive four to six cycles of etoposide and cisplatin (EP) every 3 weeks. Thoracic RT is initiated with cycle 1-3 of chemotherapy. Qd RT includes the delivery of 65 Gy in 26 fractions delivered on weekdays for a total of 33 days. Bid RT includes the delivery of 45 Gy in 30 fractions delivered on weekdays for a total of 19 days. After the chest RT and the last cycle of EP, prophylactic cranial irradiation is administered to those patients with a complete or partial remission.

Official Title
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Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy Compared With Twice-daily Radiotherapy in Limited Small-cell Lung Cancer Treated Concurrently With Cisplatin and Etoposide

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: q.d. RT
* Radiation: b.i.d.RT
* Drug: etoposide and cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic confirmation of SCLC. Imaging studies' confirmation of limited stage. No previous chest radiotherapy, chemotherapy or biotherapy. Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. White blood cell count ≥4×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L; serum creatinine and total bilirubin 1.5 times or less the upper limits of normal (ULN), aspartate aminotransferase two times or less the ULN. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Weight loss ≤10% within the past 3 months. Forced expiratory volume in 1 s >1 L. Exclusion Criteria: Previous or recent another malignancy. A myocardial infarction within 6 months or had uncontrolled congestive heart failure, uncontrolled arrhythmia. Malignant pleural or pericardial effusion. Pregnant or Lactating. Weight loss >10% within the past 3 months. Drug addiction, long-term alcohol abuse and AIDS patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: q.d. RT<br>q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin | Radiation: q.d. RT<br>* 65 Gy in 26 fractions<br>Drug: etoposide and cisplatin<br>* etoposide and cisplatin concurrent with radiotherapy<br>|
| Active Comparator: b.i.d.RT<br>b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin | Radiation: b.i.d.RT<br>* 45 Gy in 30 fractions<br>Drug: etoposide and cisplatin<br>* etoposide and cisplatin concurrent with radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small cell lung cancer, Radiotherapy, Dose fractionation