Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital of Crete | OTHER |
This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Docetaxel + Carboplatin |
|
| 2 | Experimental | Docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the overall survival between the two treatment groups | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the objective response rates between the two treatment groups | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | |
| Evaluation and comparison of the toxicity between the two treatment groups | Toxicity assessment on each chemotherapy cycle |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vassilis Georgoulias, MD | University Hospital of Crete, Dep of Medical Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Crete | Heraklion | Crete | 71110 | Greece | ||
| University General Hospital of Alexandroupolis, Dep of Medical Oncology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carboplatin | Drug | Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15 |
|
| Measurement and comparison of the health-related quality of life of patients on both treatment groups | Assessment every two cycles |
| Alexandroupoli |
| Greece |
| "IASO" General Hospital of Athnes, Dep of Medical Oncology | Athens | Greece |
| "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | Athens | Greece |
| "Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases | Athens | Greece |
| 401 Military Hospital, Medical Oncology Unit | Athens | Greece |
| Air Forces Military Hospital, Dep of Medical Oncology | Athens | Greece |
| Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | Athens | Greece |
| "Metaxa's" Anticancer Hospital of Pireaus | Piraeus | Greece |
| "Theagenion" Anticancer Hospital of Thessaloniki | Thessaloniki | Greece |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided