Perioperative Chemotherapy in Gastric Cancer

Gastric Cancer Clinical Trial

— PECORINO  

Official title:

Evaluation of Pathological Response in Patient With Resectable Gastric Cancer and Perioperative Chemotherapy FLOT Versus XELOX; Phase 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04937738
• Other study ID #: 275
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 21, 2021
• Est. completion date: July 1, 2029

Study information

• Verified date: May 2023
• Source: Ukrainian Society of Clinical Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Oxaliplatin and Capecitabin (XELOX). Main objective of the study is histopathological regression rate.

Description:

284 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 laparocopic staging patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by surgery. Subsequently another 4 cycles of FLOT or 4 cycles XELOX are applicated. Primary endpoint is histopathological regression rate, secondary endpoints are disease-free survival, perioperative morbidity and mortality, correlation between pathological responce and disease-free survival.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 284
• Est. completion date: July 1, 2029
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel
50mg/m2, d1, i.v., every 2 weeks
• Oxaliplatin
85 mg/m², d1, i.v., every 2 weeks
• Leucovorin
200 mg/m², d1, i.v., every 2 weeks
• Fluorouracil
2600 mg/m²d1 i.v. every 2 weeks
• Capecitabine
1000 mg/m² two times per day (BID), d1-14
• Oxaliplatin
130 mg/m² d1 i.v. every 3 weeks

Locations

Country	Name	City	State
Ukraine	Ukrainian Society of Clinical Oncology	Mykolaiv

Sponsors (1)

Lead Sponsor	Collaborator
Ukrainian Society of Clinical Oncology

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathological regression rate (Becker regression criteria)	To determine histopathological regression rate after FLOT regimen compared to XELOX regimen in neoadjuvant settings	2 weeks after surgery
Secondary	Chemotherapy toxicity profile	To determine and compare toxicity profile in patients receiving XELOX or FLOT regimen	at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)
Secondary	Surgical complications rate	To determine surgical complication rate and profile after different types of regimens in neoadjuvant settings	up to 90th day after surgery
Secondary	1-year disease-free survival rate	To determine the efficacy of FLOT regimen compared to XELOX regimen during the first year after the surgery	1 year after surgery
Secondary	Correlation between histopathological regression and disease-free survival	To determine correlation between histopathological regression and disease-free survival in different chemotherapeutic settings	2 years of follow-up after the last cycle of chemotherapy
Secondary	Median overall survival	To determine the efficacy of FLOT regimen compared to XELOX regimen by assessment of overall survival	5 year follow up after the last cycle of chemotherapy