Non Small Cell Lung Cancer Clinical Trial
Official title:
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
Verified date | May 2015 |
Source | Hellenic Oncology Research Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 38 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | University General Hospital of Alexandroupolis, Dep of Medical Oncology | Alexandroupolis | |
Greece | 401 Military Hospital, Medical Oncology Unit | Athens | |
Greece | Air Forces Military Hospital, Dep of Medical Oncology | Athens | |
Greece | IASO General Hospital of Athens, 1st Dep of Medical Oncology | Athens | |
Greece | Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Athens | |
Greece | Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | Athens | |
Greece | Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases | Athens | |
Greece | University Hospital of Crete | Heraklion | Crete |
Greece | Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology | Piraeus | |
Greece | Theagenion Anticancer Hospital of Thessaloniki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Hellenic Oncology Research Group | University Hospital of Crete |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to tumor progression (TTP) | 1 year | No | |
Secondary | Response rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | No | |
Secondary | Overall survival | Probability of 1-year survival (%) | No | |
Secondary | Toxicity | Toxicity assessment on each chemotherapy cycle | Yes | |
Secondary | Quality of life | Assessment every two cycles | No | |
Secondary | Symptom improvement | Assessment every two cycles | No |
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