Perioperative Chemotherapy in Gastric Cancer

NCT04937738 | Terminated Phase 2 DMC

• 1 other identifier: 275
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

perioperative chemotherapy; pathological responce rate; gastrectomy; gastric cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who complete all the treatment per protocol

  Completed treatment protocol is considered as 4 cycles neoadjuvant chemotherapy followed by curative surgery and 4 cycles of adjuvant chemotherapy.

  Up to 2 months

Secondary Outcomes (6)

• Chemotherapy toxicity profile

  at the end of XELOX cycle (each cycle is 21 days) and FLOT cycle (each cycle is 14 days)

• Surgical complications rate

  up to 90th day after surgery

• 1-year disease-free survival rate

  1 year after surgery

• Correlation between histopathological regression and disease-free survival

  2 years of follow-up after the last cycle of chemotherapy

• Median overall survival

  5 year follow up after the last cycle of chemotherapy

Study Arms (2)

Perioperative XELOX chemotherapy

ACTIVE COMPARATOR

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

Drug: Capecitabine; Drug: Oxaliplatin

Perioperative FLOT chemotherapy

EXPERIMENTAL

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

Drug: Docetaxel; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil

Interventions

Docetaxel DRUG

50mg/m2, d1, i.v., every 2 weeks

Perioperative FLOT chemotherapy

Oxaliplatin DRUG

85 mg/m², d1, i.v., every 2 weeks

Perioperative FLOT chemotherapy

Leucovorin DRUG

200 mg/m², d1, i.v., every 2 weeks

Perioperative FLOT chemotherapy

Fluorouracil DRUG

2600 mg/m²d1 i.v. every 2 weeks

Perioperative FLOT chemotherapy

Capecitabine DRUG

1000 mg/m² two times per day (BID), d1-14

Perioperative XELOX chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
• cN0-3
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Society of Clinical Oncology: lead

Study Sites (1)

National Cancer Institute

Kyiv, 03022, Ukraine

Location

Related Publications (1)

• Dobrzhanskyi O, Kopetskyi V, Ross EA, Chernoff J, Shudrak Y, Kolesnyk A, Pepenin M, Horodetskyi A, Melnitchouk N, Kondratskyi Y. Treatment discontinuation associated with perioperative toxicity of FLOT versus XELOX chemotherapy in patients with resectable gastric cancer: prospective randomized trial (PECORINO). J Gastrointest Oncol. 2025 Jun 30;16(3):909-921. doi: 10.21037/jgo-2024-921. Epub 2025 Jun 24.

  PMID: 40672074 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Oxaliplatin; Leucovorin; Fluorouracil; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Oleksii Dobrzhanskyi, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 24, 2021
• Study Start: July 21, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after initial paper is published.
• Access Criteria: By request

Locations

UA (1)