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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Samsung Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00326378
First received: May 15, 2006
Last updated: November 4, 2012
Last verified: November 2012

May 15, 2006
November 4, 2012
October 2005
March 2013   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ] [ Designated as safety issue: No ]
time to progression
Complete list of historical versions of study NCT00326378 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ] [ Designated as safety issue: No ]
  • patterns of failure [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ] [ Designated as safety issue: No ]
  • safety [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ] [ Designated as safety issue: Yes ]
  • overall survival
  • response rate
  • patterns of failure
  • safety
Not Provided
Not Provided
 
Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: consolidation chemotherapy with Docetaxel plus cisplatin
    definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin
  • Drug: CCRT arm without consolidation chemotherapy
    definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy
  • Active Comparator: CCRT arm without consolidation chemotherapy
    Docetaxel 20mg/m2 & Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy
    Intervention: Drug: CCRT arm without consolidation chemotherapy
  • Experimental: 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).
    Intervention: Drug: consolidation chemotherapy with Docetaxel plus cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
434
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00326378
2005-08-066
Not Provided
Keunchil Park/Professor, Samsung Medical Center
Samsung Medical Center
Sanofi
Principal Investigator: Keunchil Park, M.D. Samsung Medical Center
Samsung Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP