Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Study of Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation Therapy in Stage III Unresectable NSCLC

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: docetaxel
* Drug: cisplatin
* Drug: etoposide
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologic or cytologic proof of single primary non-small cell lung cancer No prior chemotherapy or radiation therapy no prior malignancy Exclusion Criteria: pregnancy or breastfeeding serious concomitant systemic disorder unintentional weight loss greater than 10%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine<br> | Drug: gemcitabine<br>* After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.<br>* Other names: Gemzar;Drug: cisplatin<br>* As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)<br>* Other names: CDDP;Drug: etoposide<br>* As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles)<br>* Other names: Etoposide phosphate;Radiation: radiation therapy<br>* In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks<br>|
| Experimental: Gemcitabine plus Docetaxel<br> | Drug: gemcitabine<br>* After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.<br>* Other names: Gemzar;Drug: docetaxel<br>* Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.<br>* Other names: Taxotere;Drug: cisplatin<br>* As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)<br>* Other names: CDDP;Drug: etoposide<br>* As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles)<br>* Other names: Etoposide phosphate;Radiation: radiation therapy<br>* In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-Year Survival | Percentage of participants alive at 2 years. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Overall Tumor Response | 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). | randomization and every 3 months up to 2 years of post-study followup | 
| Progression-Free Survival | 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. | baseline to measured progressive disease up to 2057 days | 
| Overall Survival | 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. | baseline to date of death from any cause up to 2057 days | 
| Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization | 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. | baseline to 3 months after last dose of study treatment (three 21-day cycles) |