Lung Neoplasms
Conditions
Brief summary
Primary Objective: * Response rate (by contrast CT scan) Secondary Objectives: * Progression-free survival (PFS) * Overall survival (OS)
Detailed description
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.
Interventions
DRUGDOCETAXEL
Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous
2 Gy per fraction
DRUGCISPLATIN
Pharmaceutical form: solution for infusion Route of administration: intravenous
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (by contrast CT scan) | 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation |
Secondary
| Measure | 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 |
Countries
Hong Kong
Outcome results
None listed