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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1115-3573 | Other Identifier | UTN |
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Primary Objective:
Secondary Objectives:
The duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT & docetaxel-cisplatin | Experimental | Concurrent chemo-RT: Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks - Resting period: 2 weeks - Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1&8 - Cisplatin 35 mg/m² on D1&8 - Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOCETAXEL | Drug | Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (by contrast CT scan) | 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival (PFS) | Day 1 of treatment to the date of objective disease progression | |
| Overall survival (OS) | Day 1 of treatment to the date of death due to any cause | |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Hong Kong | Hong Kong |
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| Intensity Modulated Radiotherapy (IMRT) | Radiation | 2 Gy per fraction |
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| CISPLATIN | Drug | Pharmaceutical form: solution for infusion Route of administration: intravenous |
|
| Adverse events (including oesophageal and pulmonary toxicities) |
| Informed consent signature up to 12 weeks after completion of treatment |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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