Lung Adenocarcinoma Clinical Trial
— NOTCHOfficial title:
CHEMO RESISTANCE TO PLATINUM COMPOUNDS AND NOTCH PATHWAYS IN PATIENTS RECEIVING NEOADJUVANT CHEMOTHRERAPY FOR LOCALLY ADVANCED ADENOCARCINOMA OF THE LUNG.
Every year in France, 30.000 deaths are due to lung cancer and 39.500 new cases of this disease are diagnosed (INCa 2014). Patients suffering from locally advanced non-small-cell lung cancer (NSCLC), stage IIIa, usually undergo a multimodality treatment including chemotherapy with platinum compounds before surgery (called neoadjuvant chemotherapy or induction chemotherapy). The reason of this combined modality treatment is the really poor prognosis of patients presenting a disease already spread to lymph nodes (classified N2 when the lymph node under the carina is affected). Up till now, the five-year survival of patients who underwent surgical resection of N2 NSCLC does not exceed 15%
Status | Recruiting |
Enrollment | 18 |
Est. completion date | December 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: patients of both sex, aged 75 years or younger, diagnostic specimen demonstrating an adenocarcinoma, KRAS mutation on exon 2 and codon 12 or codon 13 or triple negative, clinical pathological N2, having received a platinum-based regimen as first line therapy, at less three courses of chemotherapy must have been delivered, with only these molecules : cisplatin-vinorelbine, cisplatin-gemcitabine, cisplatin-docetaxel, cisplatin-paclitaxel, having been operated upon and having been surgically resected R0 or R1. Exclusion Criteria: patients having received more than one line of preoperative chemotherapy, having received concurrent chemo-radiotherapy as preoperative treatment, no available diagnostic specimen, patients who underwent R2 resection or no resection, patients affected by adenocarcinoma harbouring either EGFR mutation or EML4-ALK translocation, patients with pathological complete response (yT0yN0). |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
France | PUJOL | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Institut de Recherche en Cancérologie de Montpellier (IRCM) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | analysed by immunochemistry (IHC) | The biopsies of lung tumour samples will be analysed by immunochemistry (IHC) | 1 day | No |
Secondary | western blotting (WB) | The biopsies of lung tumour samples will be analysed by western blotting (WB) | 1 day | No |
Secondary | qPolymerase Chain Reaction (PCR) | The biopsies of lung tumour samples will be analysed by qPolymerase Chain Reaction (PCR) | 1 day | No |
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