Gastric and Cardia Adenocarcinomas Clinical Trial
Official title:
Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
| NCT number | NCT02491840 |
| Other study ID # | 6042 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2016 |
| Est. completion date | August 2029 |
Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay their surgical management. The completion of chemotherapy for these patients would be a bad prognosis factor according to recent data from the literature. Therefore, the aim of this research is to find prognostic markers of sensitivity to chemotherapy usually performed. The investigators are going to use biopsies realized at diagnosis and select patients "good and bad" responders. Primary purpose: To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation Secondary purposes: - To assess the impact of patients' lifestyle (via a questionnaire) on the response to chemotherapy - To study markers of cancer stem cells - To correlate clinical and molecular markers with patient survival and quality of life questionnaires - To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in frequently deregulated genes in gastric cancers. - To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73, HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature. - To correlate the abnormalities found in the with tumor stages (before and after chemotherapy) and with 5 years overall survival and progression-free patients
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | August 2029 |
| Est. primary completion date | July 2029 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: Gastric adenocarcinoma (any location) or cardia adenocarcinoma - Age> 18 years - WHO Index= 3 - Subject having signed an informed consent Exclusion Criteria: - Other cancers undergoing chemotherapy treatment - Pregnant or breastfeeding - Inability to understand information (understanding with difficulties ...) |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital, Strasbourg, france | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of expression level of Met | To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation | at 15 days | |
| Primary | Assessment of expression level of Her2 | To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation | at 15 days | |
| Primary | Assessment of expression level of FGFR2 | To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation | at 15 days |