A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC

Study Overview
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Brief Summary
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For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.

Official Title
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A Multicenter, Prospective, Randomized Study Comparing Hypofractionated Radiotherapy With Hyperfractionated Radiotherapy Combined With Concurrent Chemotherapy and Omitting Clinical Target Volumes of the Primary Tumor in Limited-stage SCLC

Conditions
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Small Cell Lung Cancer Limited Stage

Intervention / Treatment
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* Radiation: Hyperfractionated radiotherapy
* Radiation: Hypofractionated radiotherapy
* Drug: Etoposide
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically/cytologically confirmed diagnosis of SCLC. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage. Patients should be between 18 and 75 years old. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80). With adequate cardiac, pulmonary, bone marrow, hepatic and renal function. With weight loss no more than 10% within 6 months before diagnosis. Informed consent must be signed. Exclusion Criteria: Histology confirmed the mixed NSCLC components; Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.); Any disease or condition contraindicated by radiotherapy or chemotherapy; Malignant pleural effusion and pericardial effusion; Pregnant and lactating women; The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.

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 |
| --- | --- |
| Active Comparator: Hyperfrationated Arm<br>Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). | Radiation: Hyperfractionated radiotherapy<br>* Thoracic radiotherapy (45 Gy/30 fractions) for the Hyperfractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).<br>Drug: Etoposide<br>* Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.<br>* Other names: VP-16;Drug: Cisplatin<br>* Cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.<br>* Other names: DDP;|
| Experimental: Hypofrationated Arm<br>Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/15 fractions) with concurrent EP/EC chemotherapy for 2cycles, the CTVs of the tumor in lung parenchyma are omitted. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). | Radiation: Hypofractionated radiotherapy<br>* Thoracic radiotherapy (45 Gy/15 fractions) for the Hypofractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).<br>Drug: Etoposide<br>* Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.<br>* Other names: VP-16;Drug: Cisplatin<br>* Cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.<br>* Other names: DDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS, measured from the date of randomization to the date of death from any cause. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, chemotherapy, radiation dose, radiotherapy target volume