Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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Non-Small Cell Lung Cancer(NSCLC) is the leading cause of death in Korean men after stomach cancer. Surgical resection plays a main role for curative treatment. However, less than 20 % of the NSCLC patients have been found in stage I-II disease. In inoperable stage IIIA/B disease, the recommended treatment is combined chemotherapy and radiation therapy. Various kinds of combination of 2 modalities have been used either in sequential or concurrent setting. Concurrent chemoradiotherapy(CCRT) have been recognized to have better survival than radiation therapy alone or sequential therapy, but additional consolidation chemotherapy after CCRT is not yet to be determined for the beneficial role in survival gain. Docetaxel is an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin, another anticancer drug. In the present study, randomised trial will be performed to confirm the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing CCRT with the same chemotherapeutic agents in stage III inoperable NSCLC on progression free survival and overall survival.

Official Title
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A Multinational, Multicenter, Phase III Open Randomized Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-small Cell Lung Cancer (CCheIN)

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: consolidation chemotherapy with Docetaxel plus cisplatin
* Drug: CCRT arm without consolidation chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven non-small cell lung cancer Presence of measurable disease by RECIST Inoperable Stage IIIA or IIIB, proven by CT or MRI (except wet T4). However, N2 or N3 should be confirmed by PET or pathology. (For T4, PET is optional) 18 years of age or older ECOG Performance status 0-1 No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy Serum Hgb ≥ 10 gm/dL, platelet ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL Serum creatinine ≤1.25 x UNL or creatinine clearance ≥60 mlmL/min Serum bilirubin ≤ 1.5 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL FEV1> 0.8 L Patients must sign an informed consent Exclusion Criteria: Carcinoid tumor, small cell carcinoma of lung Patients with any distant metastasis History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment) Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women Women and men of childbearing potential who have no willing of employing adequate contraception

Ages Eligible for Study
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Minimum Age: 18 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: CCRT arm without consolidation chemotherapy<br>Docetaxel 20mg/m2 & Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy | Drug: CCRT arm without consolidation chemotherapy<br>* definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy<br>|
| Experimental: CCRT arm with consolidation chemotherapy<br>docetaxel 20mg/m2 & cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy, and followed by consolidation chemotherapy with 3-weekly docetaxel 35mg/m2 & cisplatin 35mg/m2 (D1,8) every 3 weeks (#3). | Drug: consolidation chemotherapy with Docetaxel plus cisplatin<br>* definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | The final analysis will be conducted when 381 events (progressions or deaths) are observed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | The final analysis will be conducted when 381 events (progressions or deaths) are observed. | 
| response rate |  | The final analysis will be conducted when 381 events (progressions or deaths) are observed. | 
| patterns of failure |  | The final analysis will be conducted when 381 events (progressions or deaths) are observed. | 
| safety |  | The final analysis will be conducted when 381 events (progressions or deaths) are observed. |