Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

Study Overview
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Brief Summary
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The purpose of this study is to determine whether hypofractionated concurrent chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.

Detailed Description
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For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm. While 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Official Title
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Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer

Conditions
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Carcinoma, Small Cell, Lung Neoplasms

Intervention / Treatment
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* Radiation: hypofractionated concurrent chemoradiotherapy
* Radiation: conventionally fractionated concurrent chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 70 years old, ECOG 0-2 patients with histologically or cytologically proved small cell lung cancer Limited disease (LD), was characterized by tumors confined to one hemithorax. It may include ipsilateral hilar, both mediastinum and both supraclavicular nodes. Metastatic lymph nodes were defined as lymph nodes with short diameter of more than 1cm or FDG uptake in PET. The thickness of pleural effusion was less than 1cm unless malignant pleural effusion was cytologically proved. In a word, stage I-IIIB excluding the patients with lung metastases should be defined as LD according to AJCC cancer staging 7th edition. No progression after 2 cycles of chemotherapy with EP. No prior history of anti-tumor treatment. No severe internal diseases and no organ dysfunction Written informed consent provided and 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
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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: hypofractionated CRT<br>hypofractionated concurrent chemoradiotherapy | Radiation: hypofractionated concurrent chemoradiotherapy<br>* For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm.<br>|
| Active Comparator: conventionally fractionated CRT<br>conventionally fractionated concurrent chemoradiotherapy | Radiation: conventionally fractionated concurrent chemoradiotherapy<br>* For patients with Limited Disease Small Cell Lung Cancer, 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 2 years | 
| local-regional failure (Incidence of tumor recurrence in local or regional area) | Incidence of tumor recurrence in local or regional area | 2 years | 
| toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0) | Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0 | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Limited Disease Small Cell Lung Cancer, concurrent chemoradiotherapy, dose fractionation