Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00192036
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- Inoperable non small cell lung cancer Stage III
- Adequate hematological parameters
- Adequate Lung function reserve
- Previous chemotherapy and thoracic radiation for non small cell lung cancer
- Presence of distant metastases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine + Cisplatin radiation Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5. Gemcitabine + Cisplatin gemcitabine Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5. Gemcitabine + Cisplatin cisplatin Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
- Primary Outcome Measures
Name Time Method Tumor Response at End of Treatment baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation) 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.
- Secondary Outcome Measures
Name Time Method Time to Progressive Disease Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years); Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.
Overall Survival Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years) Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Safety of Induction Chemotherapy every cycle (21 days) for 3 cycles (up to 10 weeks) A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.
Safety of Chemo-radiotherapy Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening.
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 physician.
š§šŖTurnhout, Belgium