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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00326378
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: consolidation chemotherapy with Docetaxel plus cisplatin Drug: CCRT arm without consolidation chemotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2005
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CCRT arm without consolidation chemotherapy
Docetaxel 20mg/m2 & Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy
 Drug: CCRT arm without consolidation chemotherapy
definitive CCRT with weekly Docetaxel/CDDP #6 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).
 Drug: consolidation chemotherapy with Docetaxel plus cisplatin
definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]
  2. response rate [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]
  3. patterns of failure [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]
  4. safety [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326378


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Sanofi
Investigators
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Principal Investigator: Keunchil Park, M.D. Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Keunchil Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00326378    
Other Study ID Numbers: 2005-08-066
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: November 2012
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action