Conditions: Gastric Cancer Gastric Adenocarcinoma Esophageal Cancer
Keywords: gastric cancer gastroesophageal junction stomach cancer intraperitoneal infusion capecitabine irinotecan cisplatin floxuridine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8
Healthy volunteers: no

Brief summary:
This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the patients with advanced stomach or gastro-esophageal junction cancers in the treatment consisting of pre- and post-surgery chemotherapies.

Detailed description:
A previous Phase-II trial conducted by the same principle investigator(s), utilizing preoperative chemotherapy and intraperitoneal consolidation, was conducted in patients with locally advanced, potentially resectable gastric cancer or cancer of the gastro-esophageal junction (GEJ), both staged as T3N0, T4N0, any TN1 or TN2 disease. The data suggest that for patients with locally advanced gastric or GEJ cancer, systemic induction therapy, curative surgery with high Ro resection rates, and IP adjuvant therapy, has acceptable toxicity and encouraging survival outcome. The Medical Research Council Adjuvant Gastric Infusional Chemotherapy (MAGIC) trial has also shown that perioperative chemotherapy - chemotherapy given both before and after surgery - can provide a significant survival benefit.

The investigators hypothesize that adjuvant intraperitoneal salvage of cancer micrometastatic residues after surgery contributes to disease-free survival. The goal of this trial is to determine whether IP Floxuridine, added to adjuvant postoperative chemotherapy, prolongs patient's survival. This will be tested during the randomized open-label trial.

Arms:
arm 1: 1. Induction treatment:

   Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.
2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
3. Randomization
4. Surgery.
5. Postoperative IP treatment:

   Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once
6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral arm 2: Same as Arm A except no postoperative IP treatment.

Interventions: intervention 1: Irinotecan intervention 2: Cisplatin intervention 3: Surgery intervention 4: Floxuridine intervention 5: Capecitabine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol document: