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

This study is ongoing, but not recruiting participants.
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
  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 progression free survival and overall survival.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: The final analysis will be conducted when 381 events (progressions or deaths) are observed. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 434
Study Start Date: October 2005
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Sanofi
Investigators
Principal Investigator: Keunchil Park, M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Keunchil Park/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00326378     History of Changes
Other Study ID Numbers: 2005-08-066
Study First Received: May 15, 2006
Last Updated: November 4, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014