Perioperative Chemotherapy in Gastric Cancer (PECORINO)

Ukrainian Society of Clinical Oncology

Status and phase: Terminated; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Docetaxel; Drug: Leucovorin; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT04937738

275

Details and patient eligibility

About

Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.

Full description

328 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.

Enrollment: 69 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
• cN0-3
• M0
• Age: 18 - 80
• ECOG: 0 - 1
• Histological type: adenocarcinoma
• Differentiation grade: G0 - G4
• No previous surgery
• No previous chemotherapy
• No concomitant severe comorbidity
• Written informed consent

Exclusion criteria

• cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery)
• Presense of distant metastases
• ECOG: 2 - 5
• Age: <18 and >80
• Severe concomitant comorbidity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Perioperative XELOX chemotherapy

Active Comparator group

Description:

Oxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

Drug: Oxaliplatin

Perioperative FLOT chemotherapy

Experimental group

Description:

Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP

Treatment:

Drug: Fluorouracil

Drug: Oxaliplatin

Drug: Leucovorin

Drug: Oxaliplatin

Drug: Docetaxel