Dissecting the Role of MIcrobioMe in gastroEsophageal Tumor: a multIdisCiplinary Longitudinal Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Gastric cancer (GC) is the second leading cause of cancer mortality and remains the fourth common cancer worldwide. Gastric and esophageal cancers treated with curative intent both have a poor prognosis with five-year survival rate varying between 30% and 40% \[Hagen\]. Therefore, even in the localized or locally advanced (LA) disease, relapse-related death remains a major challenge for curative treatment. Currently, there are several strategies for the curative treatment of GC including perioperative chemotherapy (peri-Op cht), adjuvant chemotherapy and adjuvant chemoradiotherapy. Despite the therapeutic management of localized or LA GC is well established, there is uncertainty about the power of prognostic and predictive factors to tailor anticancer treatments. In addition to that, further investigation is needed to investigate if pre-existing environment factors may act on carcinogenesis and to explore the molecular mechanisms that underlying cancer growth and invasiveness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Patients must have histologically confirmed 8th ed. American Joint Committee on Cancer (AJCC) Stage Ib to Stage III resectable GEA. A multidisciplinary discussion within surgical oncologists, medical oncologists, and radiologist will assess the disease resectability.

• Signed Written Informed Consent.

• Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and all protocol procedures.

• Males and Females, ages ≥18 years of age.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Have measurable disease based on RECIST 1.1.

• Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion and normal mucosa at baseline and at the time points specified in the Study Procedure Tables.

• Patients must be medically fit enough to undergo surgery as determined by the treating medical and surgical oncology team.

• Demonstrate adequate organ function as defined below: Hematologic Absolute neutrophil count (ANC) \>/= 1.5 X 10\^9/L; Hemoglobin \>/= 9.0 g/dL Platelets \>/= 100 X 10\^9/L prothrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin timePTT \</= 1.5 X ULN. Hepatic Total bilirubin \</= 1.5 X upper limit normal ULN (isolated bilirubin \>1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) aspartate aminotransferase AST and alanine aminotransferase ALT Albumin \</= 2.5 X ULN 1 \>/=2.5 g/dL Renal Creatinine OR Calculated creatinine clearance OR 24-hour urine creatinine clearance \</=1.5 X ULN 2 \>/= 50 mL/min \>/= 50 mL/min.

⁃ Women are eligible to participate if: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 mlU/mL and estradiol \< 40 pg/mL (\<140 pmol/L) is confirmatory\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT.

⁃ The individual methods of contraception and duration should be determined in consultation with the investigator. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.

⁃ Women must not be breastfeeding.

⁃ Men who are sexually active must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed.

⁃ Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception.

Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Chiara Alessandra Cella, MD
divisione.gastrointestinale@ieo.it
+390257489258
Backup
Cristina Mazzon
cristina.mazzon@ieo.it
Time Frame
Start Date: 2022-03-08
Estimated Completion Date: 2026-03-08
Participants
Target number of participants: 140
Treatments
patients with resectable gastroesohageal adenocarcinoma
patients with resectable GEA (including Siewert I) which are candidate to receive either peri-op treatments or upfront surgery followed by adjuvant treatments, if recommended.
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov

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