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Compares treatment options for Gastric Cancer Peritoneal Metastases
Official title Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis
ClinicalTrials.gov ID: NCT07304271
What this study is testing
What is Intraperitoneal Paclitaxel?
Intraperitoneal Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer peritoneal metastases.
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
- The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy.
- Phase 3: a large, late-stage study
- 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
- Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
- Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
- Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment.
- Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be...
- Adequate hematology assessment and serum chemistry
You likely can't join if
- Comorbidity that does not allow treatment with ST or IP paclitaxel
- Confirmed or suspected severe abdominal adhesions
- Severe coagulation disorder which precludes surgical interventions
- Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases
- Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term
- Peritoneal recurrence of gastric cancer diagnosed within 6 months after curative intent surgery
See the full eligibility criteria
- Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
- Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
- Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment.
- Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic...
- Adequate hematology assessment and serum chemistry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Age of at least 18 years
- Life expectancy of at least three months
- Assurance that adequate anti-reproductive measures will be taken during study interventions when applicable
- Comorbidity that does not allow treatment with ST or IP paclitaxel
- Confirmed or suspected severe abdominal adhesions
- Severe coagulation disorder which precludes surgical interventions
- Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases
- Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term
- Peritoneal recurrence of gastric cancer diagnosed within 6 months after curative intent surgery
- Previously received more than 2 cycles of palliative-intent systemic chemotherapy (with the specific exception of cytology positive patients without manifest peritoneal metastases) for the current gastric cancer (up to...
- Another malignancy that can affect survival within the next three years
- Known or suspected allergies against any product included in the trial interventions
- DYPD deficiency
- Pregnancy or recent delivery within 28 days postpartum or ongoing breastfeeding
- Active sex-life without use of secure contraceptive method.
- If the investigator considers the patient inappropriate for participation in the study for any other reason
- Ongoing or recent participation (within 30 days) in a clinical trial with an investigational medicinal product
The study team makes the final eligibility decision.
Where it's taking place
- Verona, Italy
- Amsterdam, Netherlands
- Gothenburg, Sweden
- Lund, Sweden
- Örebro, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
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 Verona, Italy; Amsterdam, Netherlands; Gothenburg, Sweden; Lund, Sweden; Örebro, Sweden; Stockholm, Sweden and 1 more location(s). 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.