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mFLOT Chemotherapy as First-line Treatment in GC

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

docetaxel, oxaliplatin, 5-FU, leucovorin

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Department of Oncology, Ruijin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

modified FLOT

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum tolerated dose and recommended phase II dose of modified FLOT regime

Objective response rate

Secondary Outcome Measures

Overall survival

Progression free survival

Safety: adverse events as assessed by CTCAE v4.0

Full Information

NCT ID

NCT03606928

First Posted

July 22, 2018

Last Updated

March 18, 2020

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03606928

Brief Title

mFLOT Chemotherapy as First-line Treatment in GC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

November 9, 2019 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

modified FLOT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

docetaxel, oxaliplatin, 5-FU, leucovorin

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum tolerated dose and recommended phase II dose of modified FLOT regime

Time Frame

36 months

Title

Objective response rate

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

36 months

Title

Progression free survival

Time Frame

36 months

Title

Safety: adverse events as assessed by CTCAE v4.0

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Ruijin Hospital

City

Shanghai

ZIP/Postal Code

200025

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We have no plan to make individual participant data (IPD) available to other researchers.

Learn more about this trial

mFLOT Chemotherapy as First-line Treatment in GC

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