Perioperative FLOT vs Adjuvant XELOX for CA Stomach

NCT05264896 | Recruiting Phase 3

• 1 other identifier: CRE 2020.500
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single centre randomised controlled trial, comparing perioperative FLOT versus adjuvant XELOX for locally advanced gastric and esophagogastric junction cancers. Patients with operable clinical T3 or above and N1 or above gastric and esophagastric junction cancer would be recruited. Participants would be randomised to perioperative FLOT versus adjuvant XELOX with curative radical gastrectomy. Primary outcome would be 3 year Disease Free Survival. It was calculated that 110 patients would be required to demonstrate the study hypothesis.

Conditions

Cancer of Stomach, Adenocarcinoma

Keywords

Gastric cancer; Cancer of esophagogastric junction; Chemotherapy; FLOT

Outcome Measures

Primary Outcomes (1)

• 3 year disease free survival

  3 year disease free survival (%)

  3 years

Secondary Outcomes (7)

• Overall survival

  3 years

• Adverse event of chemotherapy

  6 months

• Adverse event of surgery

  30 days

• Rate of completion of all cycles of chemotherapy

  1 year

• Postoperative hospital stay

  3 months

Study Arms (2)

FLOT

EXPERIMENTAL

Patients randomized to the FLOT arm would receive perioperative FLOT Regimen: * Docetaxel 50mg/m2, d1 * 5-FU 2600 mg/m², d1 * Leucovorin 200 mg/m², d1 * Oxaliplatin 85 mg/m², d1 * Every two weeks 4 cycles pre-op and 4 cycles post-op Granulocyte colony stimulating factor (GCSF) at 30 mu s.c. daily from Day 4 to Day 7 is recommended. Two weeks after completion of the 4 cycles of pre-op chemotherapy, reassessment endoscopy and CT scan would be performed. Surgery would be performed 4 weeks after pre-op chemotherapy if no distant metastasis was found on CT scan. Post-op adjuvant FLOT (x 4 cycles) will be started within 10 weeks after surgery.

Drug: 5-FU, Leucovorin, Oxaliplatin, Docetaxel

XELOX

ACTIVE COMPARATOR

Patients randomized to adjuvant XELOX arm would receive chemotherapy after surgery. * Capecitabine - 1,000 mg/m² twice daily. * Oxaliplatin - IV infusion, 130mg/m²

Drug: XELOX

Interventions

5-FU, Leucovorin, Oxaliplatin, Docetaxel DRUG

FLOT 4 cycles pre and post radical gastrectomy

FLOT

XELOX DRUG

XELOX 8 cycles post radical gastrectomy

XELOX

Eligibility Criteria

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

You may qualify if:

• Locally advanced adenocarcinoma of stomach or esophagogastric junction (Siewert type II and III), defined by clinical stage ≥T3 and/or ≥N1, in the absence of distant metastasis
• Surgically resectable disease based on clinical staging
• No previous gastrectomy or chemotherapy
• Age 18 or above but less than 80, and
• ECOG ≤2
• Hemoglobin \>/= 8.0 g/dL
• Neutrophils \>/= 1.500/µl
• Platelets ≥ 100.000/µl
• Creatinine clearance ≥ 50 ml/min
• Serum albumin \>25 g/L

You may not qualify if:

• Distant metastases, direct tumor invasion to organs not resectable by surgery
• Hypersensitivity or contraindication against Capacitabine, 5-FU, Leucovorin, Oxaliplatin, Docetaxel
• Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
• Peripheral polyneuropathy ≥ NCI grade II
• Severe liver dysfunction (i) ALT \>3 x upper limit of normal, and/ or (ii) total bilirubin \>1.5 x upper limit of normal (subjects with Gilbert Syndrome with total bilirubin level of \>/= 3.0 x upper limit of normal)
• Pregnancy or lactation
• Malignant secondary disease, dated back \<5 years (except in-situ carcinoma of cervix uteri, adequately treated skin basal cell carcinoma)
• Serious uncontrolled infection or cocomitant severe medical conditions

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Docetaxel; XELOX

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hon Chi Yip, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Chi Yip, FRCSEd

CONTACT

35052627; hcyip@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: March 21, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)