BridgeMD
New treatment option for Gastric Adenocarcinoma
Official title A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
ClinicalTrials.gov ID: NCT05977998
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric adenocarcinoma.
Also referred to as Taxol.
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
- To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part of the stomach) on improving outcomes in patients with gastric cancer.
- Phase 2: a mid-size study of how well it works
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 and above. There will be no upper age restriction. Because no dosing or adverse event data are currently available on the use of...
- ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
- Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
- Adequate renal, and bone marrow function:
- Leukocytes \>= 3,000/uL
You likely can't join if
- Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or lung.
- Infections such as pneumonia or wound infections that would preclude protocol therapy.
- Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who are not...
- people with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
- people, such as those with cognitive impairment, deemed unable to comply with study and/or follow-up procedures.
- people with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of...
See the full eligibility criteria
- Age 18 years and above. There will be no upper age restriction. Because no dosing or adverse event data are currently available on the use of intraperitoneal paclitaxel in patients \<18 years of age, children are...
- ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
- Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
- Adequate renal, and bone marrow function:
- Leukocytes \>= 3,000/uL
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 60,000/Ul
- Serum creatinine \<= 1.6 mg/dL
- Distant Metastatic Disease of peritoneum:
- Positive peritoneal cytology, or
- Carcinomatosis on diagnostic laparoscopy or laparotomy.
- Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued.
- English and non-English speaking patients are eligible.
- Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or lung.
- Infections such as pneumonia or wound infections that would preclude protocol therapy.
- Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who are not postmenopausal defined as no menses in greater than or equal to 12 months...
- people with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
- people, such as those with cognitive impairment, deemed unable to comply with study and/or follow-up procedures.
- people with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability...
- Previous surgery that would preclude safe cytoreduction and intraperitoneal port placement.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.