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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)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

The final analysis will be conducted when 381 events (progressions or deaths) are observed.

Safety Issue:

No

Principal Investigator

Keunchil Park, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2005-08-066

NCT ID:

NCT00326378

Start Date:

October 2005

Completion Date:

March 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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