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

• ClinicalTrials.gov Identifier: NCT00326378
• Recruitment Status: Completed
• First Posted: May 16, 2006
• Last Update Posted: June 8, 2015
• Sponsor: Samsung Medical Center
• Collaborator: Sanofi
• Information provided by (Responsible Party): Keunchil Park, Samsung Medical Center

Tracking Information

• First Submitted Date: May 15, 2006
• First Posted Date: May 16, 2006
• Last Update Posted Date: June 8, 2015
• Study Start Date: October 2005
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 4, 2012): Progression free survival [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]
• Original Primary Outcome Measures (submitted: May 15, 2006): time to progression

Current Secondary Outcome Measures (submitted: November 4, 2012)

• overall survival [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]
• response rate [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]
• patterns of failure [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]
• safety [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ]

Original Secondary Outcome Measures (submitted: May 15, 2006)

• overall survival
• response rate
• patterns of failure
• safety

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small-Cell Lung

Intervention

• 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

Study Arms

• 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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 21, 2011): 434
• Original Enrollment (submitted: May 15, 2006): 556
• Actual Study Completion Date: May 2015
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00326378
• Other Study ID Numbers: 2005-08-066
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Keunchil Park, Samsung Medical Center
• Original Responsible Party: Not Provided
• Current Study Sponsor: Samsung Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Sanofi

Investigators

• Principal Investigator: Keunchil Park, M.D.; Samsung Medical Center

• PRS Account: Samsung Medical Center
• Verification Date: November 2012