A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Pe… (NCT04797923) | Clinical Trial Compass
UnknownPhase 2
A Phase II Study of Conversion Surgery After IP Paclitaxel With XELOX Chemotherapy in AGC With Peritoneal Dissemination
South Korea43 participantsStarted 2019-12-01
Plain-language summary
Advanced gastric cancer combined with peritoneal seeind has dismal prognosis with poor response to systemic chemotherapy and with rapid aggravation of symptoms such as abdominal pain, ileus, and poor nutritional intake. Intraperitoneal (IP) chemotherapy through IP port or catheter has lower complication than HIPEC (hyperthermic intraperitoneal chemotherapy) and can deliver higher dose of chemotherapy with less systemic toxicity. IP chemotherapy combined with systemic chemotehrapy showed benefit in several clinical trials, despite lack of statistical significance in phase 3 clinical trial. Proper dose/combination of chemotherapeutic agents and indication of IP chemotherapy should be investigated through prospective, large-scale clinical trials.
Conversion surgery after cytotoxic chemotherapy showed improved survival in retrospective studies. Our hypothesis is that IP chemotherapy combined with systemic chemotherpay (capecitabine + oxaliplatin) would improve success rate of conversion surgery with R0 resection. In the present study, the treatment regimen consists of intraperitoneal paclitaxel combined with oxaliplatin and capecitabine (XELOX), and will be performed following surgery.
Who can participate
Age range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically confirmed advanced gastric cancer adenocarcinoma
. Peritoneal metastasis histopathologically confirmed by laparoscopy or laparotomy and PCI \<12 (including patients with no gross peritoneal lesion and cytology positive)
. No prior surgery for curative aim and previous chemotherapy for recurrent/metastatic gastric cancer
. Patient who is willing and able to provide written informed consent/assent for the trial
. Age between 19 and 75 years
. Measurable lesion according to RECIST 1.1 criteria
. ECOG performance status 0-1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Previous systemic chemotherapy for metastatic/recurrent advanced gastric cancer
. Patient who has distant metastasis or para-aortic lymph node metastasis or retroperitoneal metastasis except peritoneal metastasis. (But the patient who has ovarian metastasis with resectable status can be enrolled.)
. Primary tumor cannot be resected because of direct invasion to other important organ. (But, if the invaded organ can be resected together, such as spleen, gallbladder, distal pancreas, and liver, the patient can be enrolled)
. BMI ≤ 18.5 kg/m2
. HER2 positive patient (IHC 3+, 2+ with in situ hybridization +)
. Remnant gastric cancer
. Intolerable to oral intake of chemotherapeutic agent or have malabsorption syndrome
. Known additional malignancy that is progressing or requires active treatment in recent 3 years (excluding skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, or in situ cervix cancer that has undergone potentially curative therapy)