Clinical trial NCT00326378: Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2006-05-16
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression free survival
timeFrame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
Secondary outcomes:
measure: overall survival
timeFrame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
measure: response rate
timeFrame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
measure: patterns of failure
timeFrame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
measure: safety
timeFrame: The final analysis will be conducted when 381 events (progressions or deaths) are observed.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Keunchil Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.