The Role of Postoperative Cycles in the Perioperative Chemotherapy for Gastric Cancer

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Taking into account the substantial doubts concerning the potential benefit of postoperative part in the perioperative chemotherapy regimen we designed a study assessing value of this approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen will be tested in patients with locoregionally advanced gastric cancer with positive pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will be randomized to the postoperative chemotherapy or to the follow-up arm.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lublin
• Collaborator: St Johns' Oncology Center in Lublin
• Treatments: Capecitabine; Epirubicin; Oxaliplatin

Criteria

Inclusion Criteria:

• histopathologically confirmed gastric cancer

• potentially resectable, local or locoregional cancer with clinical staging cT2-4aN0-3M0. A clinical assessment of location, resectability and staging will be performed based on endoscopy, barium swallow, endoscopic ultrasound, multidetector computed tomography and diagnostic laparoscopy with cytology washing.

• medically fit to undergo a major abdominal surgery and in general condition allowing to tolerate long-lasting chemotherapy (Karnofsky Performance Status ≥70, ECOG 0-1)

Exclusion Criteria:

• Pregnancy or breast feeding.

• Diagnosed other malignancy and/or chemotherapy administrated within the last 5 years

• Gastric remnant cancer;

• Early Gastric Cancer;

• Irresectable or disseminated cancer with distant organ metastases and/or peritoneal spreading and/or positive cytology washing

• Poor performance status measured by Karnofsky index < 60 or ECOG < 1

• Clinically important active systemic disease: unstable diabetes, circulatory failure of NYHA III or IV, unstable arterial hypertension, unstable coronary heart disease, recent heart infarct or brain insult within the last 6 months, severe COPD, peripheral neuropathy of grade 2-4;

• Severe hematological abnormalities: HGB < 10.0 gm/dL and/or neutropenia < 1500 /mm3; PLT < 100 000 /mm3.

• Severe renal dysfunction requiring peritoneal dialysis, hemodialysis or hemofiltration or oliguria <20ml/h.

• Severe liver dysfunction: acute or chronic hepatitis, liver cirrhosis, liver failure, abnormal liver testing: ALAT or ASPAT or ALP >2.5 - 5.0 × upper limit; total bilirubin >2 x upper limit.

• Concommitant infection