Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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The combination of chemotherapy with radiotherapy remains the standard of therapy for patients with stage III NSCLC. A recent phase II study has presented encouraging data regarding the administration of docetaxel as consolidation treatment after definitive concurrent chemo-radiotherapy.

Detailed Description
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To evaluate whether the administration of consolidation therapy with docetaxel/carboplatin after induction chemotherapy followed by concurrent chemoradiotherapy, offers any advantage regarding time to tumor progression

Official Title
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Sequential Administration of Docetaxel/Gemcitabine Followed by Concurrent Chemo-radiotherapy, With or Without Consolidation Chemotherapy, as First Line Treatment in Patients With Unresectable Stage IIIA/IIIB NSCLC. A Randomized Phase II Study

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Gemcitabine
* Drug: Carboplatin
* Radiation: Chemoradiotherapy
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically or cytologically confirmed, unresectable locally advanced (stage IIIA/IIIB) NSCLC no previous therapy for NSCLC is allowed age >18 years bidimensionally measurable disease performance status (WHO) 0-2 absence of pleural effusion adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function life expectancy of more than 3 months written informed consent Exclusion Criteria: active infection history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) malnutrition (loss of ≥ 20% of the original body weight) performance status: 3-4 sensor or motor neuropathy > grade I second primary malignancy, except for non-melanoma skin cancer psychiatric illness or social situation that would preclude study compliance pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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: 1<br>DG -> RT | Drug: Docetaxel<br>* Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles<br>* Other names: Taxotere;Drug: Gemcitabine<br>* Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles<br>* Other names: Gemzar;Radiation: Chemoradiotherapy<br>* After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy. During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32<br>|
| Experimental: 2<br>DG -> RT -> DCarbo | Drug: Docetaxel<br>* Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles<br>* Other names: Taxotere;Drug: Gemcitabine<br>* Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles<br>* Other names: Gemzar;Drug: Carboplatin<br>* Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles<br>Radiation: Chemoradiotherapy<br>* After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy. During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32<br>Drug: Docetaxel<br>* Docetaxel 75mg/m2 IV on day 1 for 3 cycles<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor progression (TTP) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | 
| Overall survival |  | Probability of 1-year survival (%) | 
| Toxicity |  | Toxicity assessment on each chemotherapy cycle | 
| Quality of life |  | Assessment every two cycles | 
| Symptom improvement |  | Assessment every two cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Induction chemotherapy, Concurrent chemoradiotherapy, Consolidation therapy, Docetaxel, Gemcitabine, Carboplatin