Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer

Study Overview
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Brief Summary
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Primary Objective: Response rate (by contrast CT scan) Secondary Objectives: Progression-free survival (PFS) Overall survival (OS)

Detailed Description
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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.

Official Title
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Phase II Study of Concurrent Chemoradiotherapy Using IMRT (With Single Photon Emission Computed Tomography/SPECT-CT to Define Functional Lung Volume and Positron Emission Tomography/PET to Define Gross Tumour Volume/GTV) and Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer (NSCLC)

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Drug: DOCETAXEL
* Radiation: Intensity Modulated Radiotherapy (IMRT)
* Drug: CISPLATIN


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Pathologically proven locally advanced, inoperable, confirmed by PET scan (thorax/ upper abdomen) to be International stage III (2009) NSCLC and without multifocal tumours in the lung Disease volume encompassible within a tolerable Planning Target Volume treated to 66 Gy FEV1 (Force Expiratory Volume in 1 Second) >1000 ml Hemoglobin ≥ 9.0 g/dl Absolute neutrophil count (ANC) ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3 Total bilirubin ≥ 1.5 times the upper limit of normal ALT (Alanine Aminotransferase) and AST (Aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement) ECOG (Eastern Cooperative Oncology Group) PS 0-1 Exclusion criteria: Previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents Inadequate lung function (Exercise tolerance less than 1 FOS/Fight of stairs, FEV1 < 1 L/sec, or raised pCO2) History of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80 Pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry Participation in a clinical trial with any investigational drug used and within 30 days prior to study entry The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT & docetaxel-cisplatin<br>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 | Drug: DOCETAXEL<br>* Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous<br>Radiation: Intensity Modulated Radiotherapy (IMRT)<br>* 2 Gy per fraction<br>Drug: CISPLATIN<br>* Pharmaceutical form: solution for infusion Route of administration: intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Adverse events (including oesophageal and pulmonary toxicities) |  | Informed consent signature up to 12 weeks after completion of treatment |