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| ID | Type | Description | Link |
|---|---|---|---|
| TomoCT |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
This non-randomized Phase I/II study is designed to determine the maximum tolerated dose (MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in patients with LA-NSCLC. All patients will receive weekly administrations of docetaxel 20 mg/m² and cisplatin 20 mg/m2 concurrently with radiotherapy. Radiotherapy will be delivered using helical tomotherapy in 30 daily fractions over six weeks. Patients should have recovered fully from induction concurrent chemoradiotherapy before they continue with the consolidation chemotherapy phase. Patients will be entered in cohorts of at least 5 subjects.
The first cohort of patients will receive 30 fractions of 2Gy in six weeks up to a total dose of 60Gy. The concurrent chemotherapy starts at day 1 of the radiotherapy and will be administered 2-4 hours before the radiotherapy.
The radiotherapy fraction size will be escalated to 2.36Gy in three steps.
Dose escalation steps are:
30*2.00Gy = 60.0Gy (BED= 70.8Gy10 NID2= 60.0Gy) 30*2.12Gy = 63.6Gy (BED= 75.9Gy10 NID2= 64.2Gy) 30*2.24Gy = 67.2Gy (BED= 81.5Gy10 NID2= 68.5Gy) 30*2.36Gy = 70.8Gy (BED= 86.3Gy10 NID2= 72.9Gy) If MTD is not reached, protocol modification allowing further escalation can be considered.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatinum | Drug | |||
| Docetaxel | Drug | |||
| Tomotherapy | Device |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the feasibility and toxicity of radiation dose escalation using helical tomotherapy concurrently with chemotherapy (docetaxel-cisplatin combination) in stage III locally advanced non small cell lung cancer (LA-NSCLC). |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate efficacy parameters in terms of overall response rate, progression free survival and overall survival. To monitor quality of life (QOL) before, during and after treatment. |
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Inclusion Criteria:
Informed consent is required.
Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
Patients must have a stage III unresectable LA-NSCLC:
Males or females aged between 18 and 75 years.
Life expectancy of at least 12 weeks.
ECOG performance status 0,1 or2.
Weight loss ≤ 10% within the last 3 months.
Laboratory requirements at entry:
• Blood cell counts: i. Absolute neutrophils ≥ 2.0 x 109/L ii. Platelets ≥ 100 x 109/L iii. Haemoglobin ≥ 11 g/dl
• Renal function: i. Serum creatinine < 1 x the upper limit of normal (UNL). ii. In case of borderline value of serum creatinine, the 24h creatinine clearance should be > 60 ml/min.
• Hepatic function: i. Serum bilirubin < 1 x UNL ii. ASAT and ALAT < 2.5 x UNL iii. alkaline phosphatase < 5 x UNL iv. Patient with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase> 2.5 x UNL is not eligible for the study.
Lung function tests at entry:
Adequate cardiac function.
Patient with either measurable and/or non-measurable lesion (according to RECIST criteria, A1).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Bral, MD | Contact | 003224776415 | samuel.bral@uzbrussel.be | |
| Nicolas Fontaine, Mr | Contact | 0032 2 477 54 61 | nicolas.fontaine@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Bral, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Recruiting | Jette | 1090 | Belgium |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| 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 |