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Multicenter Phase II Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

Multicenter Phase II Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer


Inclusion Criteria:



- Inoperable non small cell lung cancer Stage III

- Adequate hematological parameters

- Adequate Lung function reserve

Exclusion Criteria:

- Previous chemotherapy and thoracic radiation for non small cell lung cancer

- Presence of distant metastases

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response at End of Treatment

Outcome Description:

Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Outcome Time Frame:

baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

8984

NCT ID:

NCT00192036

Start Date:

August 2004

Completion Date:

November 2009

Related Keywords:

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

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