A Prospective Randomized Study Comparing the Target Volume for Limited-stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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We hypothesized that the local control for both arms were not statistically significant, when irradiation to the post-induction chemotherapy tumor volume is compared with irradiation to the pre-induction chemotherapy tumor volume.While elective nodal irradiation will be omitted for both arms.

Official Title
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Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer

Conditions
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Carcinoma of Lung, Small Cell, Limited Stage

Intervention / Treatment
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* Radiation: hyperfractionated radiation therapy for both arms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included. The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy. Karnofsky performance status was ≥ 80. Forced expiratory volume at 1 second (FEV1) ≥ 1 L. Had measurable or assessable disease. Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L. Serum creatine and bilirubin < 1.5 × the upper normal limit (UNL), aminotransferase < 2 × UNL. Weight loss was less than 10% within 6 months before diagnosis. Written informed consent was required from all patients. Exclusion Criteria: Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.

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: study arm<br>For patients who are randomized to study arm, (i.e. to irradiate the post-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the post-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy（1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks） | Radiation: hyperfractionated radiation therapy for both arms<br>* 1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms<br>|
| Active Comparator: control arm<br>For patients who are randomized to control arm, (i.e. to irradiate the pre-chemotherapy tumor extent) the clinical target volume-tumor (CTV-T) includes the pre-chemotherapy gross tumor volume-tumor (GTV-T) with a margin of 0.8 cm. Chemotherapy includes etoposide 100mg/m2 d1-d3 combine with cisplatin 80mg/m2 d1 at 21-day interval for 4 cycles. Radiotherapy will be administered with cycle 3 chemotherapy (1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks). | Radiation: hyperfractionated radiation therapy for both arms<br>* 1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local-regional progression |  | at least 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | at least 1 year |