mFLOT Chemotherapy as First-line Treatment in GC

Sponsor

Ruijin Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03606928

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A single center phase 1b/2 trail to identified suitable dosage and its efficacy of modified FLOT regime in Chinese gastric cancer patients. This trial is designed to identified recommended phase II dose (RP2D) of modified FLOT in Chinese patients, and to evaluate the efficacy of modified FLOT regime as first-line for advanced or metastatic gastric cancer.

This trial is in 2 stages: the first stage will establish the maximum tolerated dose (MTD) and RP2D of docetaxel and oxaliplatin in FLOT regime. In the second stage, the efficacy of modified FLOT will be assessed by response rate.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: docetaxel, oxaliplatin, 5-FU, leucovorin	Phase 1/Phase 2

Detailed Description

The RP2D of FLOT regime will be established with a standard 3+3 design, starting with the dose of 40mg/m2 docetaxel (dose level 1) and 65mg/m2 oxaliplatin (dose level 1). The plan of dose escalation will be found in following table. Chemotherapy will be administered two-weekly (maximum 12 cycles) until progression of disease, intolerable toxicity or withdraw of patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Modified FLOT Chemotherapy as First-line Treatment in Advanced or Metastatic Gastric Cancer

Actual Study Start Date :

Jul 1, 2018

Actual Primary Completion Date :

Nov 9, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: modified FLOT modified FLOT Docetaxel 40mg/m2 ivgtt day 1 over 1 hour Oxaliplatin 65mg/m2 ivgtt day 1 over 2hours Dose escalation will be performed. Leucovorin 200mg/m2 ivgtt day 1 over 2 hours 5-FU 2200mg/m2 civ over 24 hours	Drug: docetaxel, oxaliplatin, 5-FU, leucovorin This is a single-arm study with all patients receiving mFLOT chemotherapy.

Arm

Intervention/Treatment

Experimental: modified FLOT

modified FLOT Docetaxel 40mg/m2 ivgtt day 1 over 1 hour Oxaliplatin 65mg/m2 ivgtt day 1 over 2hours Dose escalation will be performed. Leucovorin 200mg/m2 ivgtt day 1 over 2 hours 5-FU 2200mg/m2 civ over 24 hours

Drug: docetaxel, oxaliplatin, 5-FU, leucovorin

This is a single-arm study with all patients receiving mFLOT chemotherapy.

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose and recommended phase II dose of modified FLOT regime [36 months]
Objective response rate [36 months]

Secondary Outcome Measures

Overall survival [36 months]
Progression free survival [36 months]
Safety: adverse events as assessed by CTCAE v4.0 [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male/female patients aged from 18 to 75 years.
Histologically confirmed gastric adenocarcinoma.
Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
At least one measurable lesion should be confirmed by imaging examination.
ECOG performance status 0 or 1
Adequate bone marrow function:

Absolute neutrophil count (ANC) ≥1.5x109/L White blood count ≥3.5x109/L Platelets ≥80x109/L Hemoglobin (Hb) ≥90g/L (can be post-transfusion)

Adequate renal function: Creatinine Clearance of >50ml/min
Adequate liver function:

Serum bilirubin <22 umol/L ALT/AST ≤2.5x ULN, for patient with liver metastasis ALT/AST ≤5x ULN 10. Adequate coagulation profile International Normalised Ratio (INR) < 1.5 Activated Prothrombin Time (APTT) < 1.5xULN 11. Without brain metastasis and peripheral nerve diseases 12. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

With second primary malignant diseases
Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of leucovorin, oxaliplatin, 5-FU or docetaxel
With uncontrollable complications
Inadequate organ function
Pregnancy or of child bearing potential.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology, Ruijin Hospital	Shanghai		China	200025

Sponsors and Collaborators

Ruijin Hospital

Investigators

Principal Investigator: Jun Zhang, MD & Ph. D, Ruijin Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Jun Zhang, Chief, Department of Oncology, Ruijin Hospital

ClinicalTrials.gov Identifier:

NCT03606928

Other Study ID Numbers:

mFLOT-GC

First Posted:

Jul 31, 2018

Last Update Posted:

Mar 20, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2020