Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.

Detailed Description
-----------------
This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Official Title
-----------------
Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy

Conditions
-----------------
Carcinoma, Small Cell, Lung Neoplasms

Intervention / Treatment
-----------------
* Radiation: high-dose TRT
* Radiation: standard-dose TRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 70 years old, ECOG 0-2. Patients with histologically or cytologically proved small cell lung cancer. Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD. Has 1-4 extracranial metastatic lesions. No brain or central nervous system (CNS) metastases. No prior history of anti-tumor treatment. Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks. No severe internal diseases and no organ dysfunction. Written informed consent provided. Exclusion Criteria: Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable. Active heart disease or acute myocardial infarction happen in six months. Psychiatric history. Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG). Uncontrolled diabetes or hypertension. Interstitial pneumonia or Active pulmonary fibrosis. Acute bacterial or fungal infection. Oral or intravenous use of steroids.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-dose TRT<br>high-dose thoracic radiotherapy X-ray RT | Radiation: high-dose TRT<br>* every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f<br>|
| Active Comparator: standard-dose TRT<br>standard-dose thoracic radiotherapy XRT | Radiation: standard-dose TRT<br>* every day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | The time interval between diagnosis and death | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | The time interval between diagnosis and disease progression | 2 years | 
| Incidence of tumor recurrence in local or regional area | Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients | 2 years | 
| Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0 | Number of patients experienceing any toxicities induced by radiotherapy or chemotherapy divided by number of all enrolled patients | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extensive Stage Small Cell Lung Cancer, thoracic radiotherapy, radiotherapy regimen