Efficacy Study of Additional Chemotherapy After Concurrent Chemoradiation in Non-small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Samsung Medical Center
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
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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 May 22, 2013