Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Samsung Medical Center Sanofi-Aventis
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00326378

Purpose

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 time to progression and overall survival.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: docetaxel	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

time to progression

Secondary Outcome Measures:

overall survival
response rate
patterns of failure
safety

Estimated Enrollment:	556
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326378

Contacts

Contact: Keunchil Park, M.D.

82-2-3410-3459

kpark@smc.samsung.co.kr

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Principal Investigator: Keunchil Park, M.D.

Sponsors and Collaborators

Samsung Medical Center

Sanofi-Aventis

Investigators

Principal Investigator:

Keunchil Park, M.D.

Samsung Medical Center

More Information

Study ID Numbers:	2005-08-066
Study First Received:	May 15, 2006
Last Updated:	May 15, 2006
ClinicalTrials.gov Identifier:	NCT00326378
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009