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

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: CCRT arm without consolidation chemotherapy; Drug: consolidation chemotherapy with Docetaxel plus cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00326378

2005-08-066

Details and patient eligibility

About

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.

Enrollment: 434 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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434 participants in 2 patient groups

CCRT arm without consolidation chemotherapy

Active Comparator group

Description:

Docetaxel 20mg/m2 \& Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy

Treatment:

Drug: CCRT arm without consolidation chemotherapy

CCRT arm with consolidation chemotherapy

Experimental group

Description:

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).

Treatment:

Drug: consolidation chemotherapy with Docetaxel plus cisplatin