NCT04547725 Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis
| NCT ID | NCT04547725 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2020-09-16 |
| Primary Completion | 2026-03-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2020-09-16 with a primary completion date of 2026-03-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Approximately 15% of gastric adenocarcinoma patients presents with peritoneal carcinomatosis (PC) at the first encounter and is regarded as an unresectable and end-stage disease. The recommended treatment with palliative chemotherapy alone yields a poor clinical efficacy. Emerging evidences suggest the survival benefits of complete cytoreductive surgery (CRS) combined with normothermic intraperitoneal chemotherapy (N-IPEC) for gastric adenocarcinoma with limited PC. Objective: To evaluate the 6-month disease control rate (DCR) of complete CRS combined with N-IPEC and systemic chemotherapy for gastric adenocarcinoma with limited PC. Patients and methods: Patients having gastric adenocarcinoma with PCI ≤ 10 (Arm-A) or positive peritoneal wash cytology (CY1/P0) (Arm-B) will be enrolled. Patients with other distant metastasis, including brain, lung, liver, bone, will be excluded. All patients should undergo ≥ D2 gastrectomy and complete CRS followed by N-IPEC (paclitaxel\] and systemic chemotherapy (high-dose fluorouracil and cisplatin \[P-HDFL\], or capecitabine and oxaliplatin \[CAPOX\]). N-IPEC (paclitaxel) will be administered in combination with systemic P-HDFL or CAPOX on day 1,8,15 or day 1,8 for each cycle, respectively. The disease status will be evaluated every 12 weeks based on the computed tomography scan, and the clinical evaluation (outpatient follow-up) will be performed every 2 weeks for whom receiving P-HDFL and every 3 weeks for whom receiving CAPOX. Patients will receive maximal 6 cycles N-IPEC with P-HDFL or 8 cycles N-IPEC with CAPOX. After N-IPEC is discontinued, P-HDFL or CAPOX will be continued alone until disease progression or death. The primary endpoint of this study is 6-month DCR, and the secondary endpoints include 6-month response rate for ascites, 1-year progression-free survival (PFS) and overall survival (OS), 3-year PFS and OS, and safety profiles. Based on Simon's minimax two-stage design, this trial will be carried out in two stages. In stage I, a total number of 13 (Arm-A) / 16 (Arm-B) patients is accrued. If there are ≤ 6 (Arm-A) / ≤ 14 (Arm-B) progression-free among these 13 (Arm-A) / 16 (Arm-B) patients, the study will be early stopped. Otherwise, additional 17 (Arm-A) / 2 (Arm-B) patients will be accrued in stage II, resulting in a total number sample size of 30 (Arm-A) / 18 (Arm-B). Expected result: A ≥ 75% (Arm-A) / ≥ 95% (Arm-B) 6-month DCR could be achieved for gastric adenocarcinoma patients with limited PC (Arm-A) / with CY1P0 (Arm-B) via this treatment strategy (complete CRS + N-IPEC + P-HDFL or CAPOX) -i.e., if there are ≥ 21 (Arm-A) / ≥ 16 (Arm-B) progression-free among the 30 (Arm-A) / 18 (Arm-B) enrolled patients, we will reject the null hypothesis and claim that the treatment is promising.
Eligibility Criteria
\[Inclusion criteria\] 1. Age 20 to 75 years old. 2. Blood tests: 1. White blood cells \> 4,000/mm3, neutrophils \> 1,500/mm3, platelets \> 100,000/mm3. 2. Serum creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/min. 3. Serum bilirubin \< 2 mg/dl. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1. 4. Not legal incapacity. 5. Newly diagnosed gastric adenocarcinoma, including Siewert III adenocarcinoma of the cardia, with limited peritoneal carcinomatosis (PCI ≤ 10) or positive peritoneal wash cytology (CY1/P0) . \[Exclusion criteria\] 1. Prior malignancy within 3 years or with detectable signs of recurrence. 2. Newly diagnosed gastric adenocarcinoma having been treated by preoperative systemic or intraperitoneal chemotherapy. 3. Presence of comorbidities, including liver cirrhosis (≥ Child B), decompensated heart failure (New York Heart Association \[NYHA\] Class III or IV congestive heart failure), poorly-controlled chronic obstructive pulmonary disease. 4. ≥ American Society of Anesthesiologists Classification (ASA Class) Class 3. 5. Pregnancy or breastfeeding. 6. Intolerability of chemotherapeutic agents in this study: 1. N-IPEC paclitaxel (all patients). 2. Capecitabine or oxaliplatin (patients who receive CAPOX regimen). 3. Cisplatin or 5-fluorouracil (patients who receive P-HDFL regimen). 7. Distant metastases (e.g. liver, lung, bone) except for the peritoneum, intra-abdominal lymph node, and ovary. 8. Extensive PC (PCI \> 10). 9. Siewert I or II adenocarcinoma of the cardia. 10. Other patients inappropriate for this study in the opinion of the investigators.
Contact & Investigator
I-Rue Lai, MDPHD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT04547725 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 75 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04547725 currently recruiting?
Yes, NCT04547725 is actively recruiting participants. Contact the research team at yhhdean@gmail.com for enrollment information.
Where is the NCT04547725 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT04547725 clinical trial?
NCT04547725 is sponsored by National Taiwan University Hospital. The principal investigator is I-Rue Lai, MDPHD at National Taiwan University Hospital. The trial plans to enroll 48 participants.
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