Gastric Adenocarcinoma study: Neoadjuvant chemotherapy vs Olanzapine
Official title GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer
ClinicalTrials.gov ID: NCT07581405
What this study is testing
What is Neoadjuvant chemotherapy?
Neoadjuvant chemotherapy is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for gastric adenocarcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, clinical trial designed to look at the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years of age at time of consent
- Eastern Cooperative Oncology Group (ECOG) score of 0-2
- Histologically confirmed gastric adenocarcinoma, documented by biopsy.
- Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.
- Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.
You likely can't join if
- Active infection requiring systemic therapy
- Uncontrolled HIV/AIDS or active viral hepatitis
- Pregnant or nursing
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment...
- Patients with a feeding tube (e.g., gastrostomy or jejunostomy) who receive their primary source of nutritional intake via enteral tube feeding at...
- Other major comorbidity, as determined by the study PI
See the full eligibility criteria
- Age ≥ 18 years of age at time of consent
- Eastern Cooperative Oncology Group (ECOG) score of 0-2
- Histologically confirmed gastric adenocarcinoma, documented by biopsy.
- Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.
- Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.
- Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board informed consent form and HIPAA authorization.
- Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study
- Active infection requiring systemic therapy
- Uncontrolled HIV/AIDS or active viral hepatitis
- Pregnant or nursing
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of this investigational regimen, as determined by the treating medical...
- Patients with a feeding tube (e.g., gastrostomy or jejunostomy) who receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment are excluded because the primary endpoints of...
- Other major comorbidity, as determined by the study PI
- Patients currently taking medications that may interact with olanzapine, including, but not limited to, other anti-psychotics, CNS depressants, or dopamine agonists.
- Patients with a clinically significant cardiac history or clinically significant QTc prolongation that, in the opinion of the treating investigator, would make olanzapine administration unsafe.
- Patients with uncontrolled hyperglycemia that, in the opinion of the treating investigator, would make olanzapine administration unsafe.
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.