mFLOT Chemotherapy as First-line Treatment in GC

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606928
• Other study ID #: mFLOT-GC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 1, 2020
• Est. primary completion date: November 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male/female patients aged from 18 to 75 years.

2. Histologically confirmed gastric adenocarcinoma.

3. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.

4. At least one measurable lesion should be confirmed by imaging examination.

5. ECOG performance status 0 or 1

6. 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)

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

8. 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:

1. With second primary malignant diseases

2. Any contraindication or known hypersensitivity reaction to any of the study drugs, or components of leucovorin, oxaliplatin, 5-FU or docetaxel

3. With uncontrollable complications

4. Inadequate organ function

5. Pregnancy or of child bearing potential.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• docetaxel, oxaliplatin, 5-FU, leucovorin
This is a single-arm study with all patients receiving mFLOT chemotherapy.

Locations

Country	Name	City	State
China	Department of Oncology, Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose and recommended phase II dose of modified FLOT regime		36 months
Primary	Objective response rate		36 months
Secondary	Overall survival		36 months
Secondary	Progression free survival		36 months
Secondary	Safety: adverse events as assessed by CTCAE v4.0		36 months