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

Phase 3

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: CCRT arm without consolidation chemotherapy; Drug: consolidation chemotherapy with Docetaxel plus cisplatin

• Registration Number: NCT00326378
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-16
• Status Verified: 2012-11
• Primary Completion: 2013-03
• Study Completion: 2015-05
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 434

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCRT arm without consolidation chemotherapy	CCRT arm without consolidation chemotherapy	Docetaxel 20mg/m2 \& Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy
CCRT arm with consolidation chemotherapy	consolidation chemotherapy with Docetaxel plus cisplatin	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).

Primary Outcome Measures

Name	Time	Method
Progression free survival	The final analysis will be conducted when 381 events (progressions or deaths) are observed.

Secondary Outcome Measures

Name	Time	Method
safety	The final analysis will be conducted when 381 events (progressions or deaths) are observed.
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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of