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

NCT ID: NCT00326378

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 434 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2015-05-31

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CCRT arm without consolidation chemotherapy

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

Group Type: ACTIVE_COMPARATOR

CCRT arm without consolidation chemotherapy

Intervention Type: DRUG

definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy

CCRT arm with consolidation chemotherapy

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).

Group Type: EXPERIMENTAL

consolidation chemotherapy with Docetaxel plus cisplatin

Intervention Type: DRUG

definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin

Interventions

consolidation chemotherapy with Docetaxel plus cisplatin

definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin

Intervention Type: DRUG

CCRT arm without consolidation chemotherapy

definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keunchil Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keunchil Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

Ahn JS, Ahn YC, Kim JH, Lee CG, Cho EK, Lee KC, Chen M, Kim DW, Kim HK, Min YJ, Kang JH, Choi JH, Kim SW, Zhu G, Wu YL, Kim SR, Lee KH, Song HS, Choi YL, Sun JM, Jung SH, Ahn MJ, Park K. Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04. J Clin Oncol. 2015 Aug 20;33(24):2660-6. doi: 10.1200/JCO.2014.60.0130. Epub 2015 Jul 6.

Reference Type: DERIVED

PMID: 26150444 (View on PubMed)

Other Identifiers

2005-08-066

Identifier Type: -

Identifier Source: org_study_id