NCT03618758CompletedPhase 1/2
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy
Source: ClinicalTrials.gov · Last updated 5 Dec 2023
Brief summary (registry, in English)
Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results. This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 2 Aug 2018
- Start date
- 24 Dec 2018
- Primary completion date
- 31 Aug 2023
- Lead sponsor
- Seoul National University Bundang Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03618758
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 35
- From 24 Dec 2018 to the primary completion date, 31 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with other major medical disease or malignant tumors other than gastric cancer
Other
- Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
- Pregnant, breast-feeding women or with birth plan
- Patients refusing treatment
Who the study is looking for
- Biopsy proven adenocarcinoma of gastric origin, primary or recurrent
- Identification of Peritoneal seeding by CT or diagnostic laparoscopy
- Patients confirmed to receive mFOLFOX6 on multidisciplinary outpatient clinic
- No previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer
- Labs adequate for chemotherapy (within 2 weeks of enrollment)
- Absolute Neutrophil Count: ≧ 1,500/mm³
- Hemoglobin level: ≧ 8.0g/dL
- Platelet Count: ≧ 10×104/mm³
- AST (GOT), ALT (GPT): ≦ 100U/L
- Total Bilirubin: ≦ 2.0mg/dL
- Creatinine Clearance (CCl): ≧ 50mL/min
- ECOG 0 - 2
- Her-2 negative on endoscopic biopsy
- Age ≧ 20, \< 80
- Signed Informed consent form
Age in the registry: 20 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.