Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00191139
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- histologic or cytologic proof of single primary non-small cell lung cancer
- No prior chemotherapy or radiation therapy
- no prior malignancy
- pregnancy or breastfeeding
- serious concomitant systemic disorder
- unintentional weight loss greater than 10%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine radiation therapy - Gemcitabine plus Docetaxel radiation therapy - Gemcitabine gemcitabine - Gemcitabine cisplatin - Gemcitabine etoposide - Gemcitabine plus Docetaxel gemcitabine - Gemcitabine plus Docetaxel docetaxel - Gemcitabine plus Docetaxel etoposide - Gemcitabine plus Docetaxel cisplatin -
- Primary Outcome Measures
Name Time Method 2-Year Survival 2 years Percentage of participants alive at 2 years.
- Secondary Outcome Measures
Name Time Method Number of Patients With Overall Tumor Response randomization and every 3 months up to 2 years of post-study followup Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).
Progression-Free Survival baseline to measured progressive disease up to 2057 days Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.
Overall Survival baseline to date of death from any cause up to 2057 days Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.
Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization baseline to 3 months after last dose of study treatment (three 21-day cycles) LCSS measures physical \& functional dimensions. The patient scale contains 9 items, 3 summation \& 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph
🇰🇷Suwon-City, Korea, Republic of