Health TrialsbyHealthPanel

Perioperative FLOT vs Adjuvant XELOX for CA Stomach

ConditionCancer of Stomach, Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5-FU, Leucovorin, Oxaliplatin, Docetaxel

    Drug

    FLOT 4 cycles pre and post radical gastrectomy

  • XELOX

    Drug

    XELOX 8 cycles post radical gastrectomy

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: FLOTExperimental treatment 1 intervention
Group B: XELOXActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3 year disease free survival

3 year disease free survival (%)

Time frame
3 years

Secondary outcomes

1

Overall survival

Overall survival (%)

Time frame
3 years
2

Adverse event of chemotherapy

Adverse event of chemotherapy (%)

Time frame
6 months
3

Adverse event of surgery

Adverse event of surgery (%)

Time frame
30 days
4

Rate of completion of all cycles of chemotherapy

Completion rate of all cycles of chemo (%)

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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