Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer

Randomized Phase II Trial of 4-regimen (SP, FL/Tax, FL/Doc, FOLFOX) in Patients With Recurrent or Metastatic Gastric Cancer

This study is to evaluate the antitumor activity (i.e. progression free survival, overall survival, response rate, etc), safety and quality of life in patient with recurrent or metastatic gastric cancer during 4-regimen (i.e. SP, FL/Tax, FL/Doc, FOLFOX) based chemotherapy. In addition, it is to evaluate efficacy and adverse events of anticancer agents according to the results of pharmacogenetic study.

Study Overview

• Status: Completed
• Conditions: Recurrent or Metastatic Gastric Cancer
• Intervention / Treatment: Drug: SP; Drug: FL/Tax; Drug: FL/Doc; Drug: FOLFOX

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the stomach
• Unresectable metastatic disease or recurred AGC
• Age ≥ 20 years old
• Eastern Cooperative Oncology Group performance status 0-2
• Estimated life expectancy > 12weeks
• Patients with pre-treatment(radiotherapy, chemotherapy) is not carried out. (However, adjuvant chemotherapy using one kind of medication is allowed. It must passed more than 6 months since end of the treatment.) Conventional radiation therapy should be performed before more than 2 weeks. And it is not allowed radiation therapy on primary tumor, measurable lesions, and abdominal
• According to RECIST ver.1.1, using imaging techniques (CT or MRI), measurement possible disease or not measurable, but assessable disease
• Screening laboratory values within the following limits : Hemoglobin ≥ 9 g/dL, Absolute neutrophil count ≥ 1.5 x 10³/L, Platelet count ≥ 75 x 10³/L, Serum creatinine ≤ 1.5 x UNL, Creatinine clearance ≥ 50 mL/min, AST/ALT ≤ 5.0 x UNL
• The patient or protector have to sign a consent form. And he should be able to understand the right to withdraw consent without disadvantage.

Exclusion Criteria:

• Prior chemotherapy (however, previous (neo-)adjuvant chemotherapy allowed if finished at least 6month ago except S-1, Paclitaxel, Docetaxel, Oxaliplatin . Allowed 5-FU, Cisplatin if finished 6month ago)
• Patients with oral intake is impossible or with malabsorption syndrome
• Patients with medically uncontrolled severe complications or infection
• Patients who have central nervous system disorders, mental disorders, or evidence of CNS metastases
• Patient with diagnosed active overlapping cancer within the past 5years except adequately treated carcinoma insitu of the cervix, basal or squamous cell carcinoma of skin
• The possibility(will) of pregnancy , or pregnant and lactating women
• Patients with clinically significant heart disease
• Progression of gastric lesions is not possible to evaluate
• During clinical trials, patient receiving of systemic chemotherapy or other clinical trials drugs or radiotherapy (However, it is possible that palliative radiotherapy treatment for pain relief on primary lesion after more than 2 weeks)
• Peripheral neuropathy of Grade 2 or greater.
• Patients who taking drugs to change of pharmacological activity of S-1 medicine(Warfarin, phenytoin, allopurinol etc.). Except regular treatment of corticosteroids(or equivalent drugs). However, it is allowed the purposes for pre-treatment of study drugs and the control of nausea and vomiting. (However, it is allowed the treatment for acute allergic reactions, or the treatment with low doses (methylprednisolone 20mg or less, or the equivalent drug) from about 6 months)

• Other cases

  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
  • Psychological condition or dementia that would not permit the subject to complete the study or sign informed consent
  • Patients with dropout sure in clinical trials or cannot be regular follow-up following reasons. For example, psychological, social, family, geographic reasons or a difficult condition of compliance with clinical trial and proper follow up.
  • Poorly controlled chronic liver disease or diabetes mellitus
  • Else, in the investigator's opinion, should exclude the patient from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SP(S-1 with cisplatin); SP <Every 3 weeks>; Day 1~14 : TS-1 80mg/m2/day (PO); Day 1 : CDDP 60mg/m2/day IVF 2hours; Day 15~21 : Rest	Drug: SP; Day 1~14 : TS-1 80mg/m2/day (PO),; Day 1 : CDDP 60mg/m2/day IVF 2hours,; Day 15~21 : Rest.; Other Names: TS-1® with Cisplatin
Active Comparator: FL/Tax(Paclitaxel with Leucovorin with 5-FU); FL/Tax <Every q 3 weeks>; Day1 : Paclitaxel 175mg/m2 IVF for 2hours; Day1 : Leucovorin 20mg/m2 IVF for 1hour; Day1~3 : 5-FU 1000mg/m2 IVF for 24hours	Drug: FL/Tax; Day1 : Paclitaxel 175mg/m2 IVF for 2hours; Day1 : Leucovorin 20mg/m2 IVF for 1hour; Day1~3 : 5-FU 1000mg/m2 IVF for 24hours; Other Names: Paclitaxel with Leucovorin with 5-FU
Active Comparator: FL/Doc(Decetaxel with Leucovorin with 5-FU); FL/Doc <Every q 3 weeks>; Day1 : Docetaxel 75mg/m2 IVF for 1hour; Day1 : Leucovorin 20mg/m2 IVF for 1hour; Day1~3 : 5-FU 1000mg/m2 IVF for 24hours	Drug: FL/Doc; Day1 : Docetaxel 75mg/m2 IVF for 1hour; Day1 : Leucovorin 20mg/m2 IVF for 1hour; Day1~3 : 5-FU 1000mg/m2 IVF for 24hours; Other Names: Docetaxel with Leucovorin with 5-FU
Active Comparator: FOLFOX(Oxaliplatin with Leucovorin with 5-FU); FOLFOX <Every q 2 weeks> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours	Drug: FOLFOX; D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours; Other Names: Oxaliplatin with Leucovorin with 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival(PFS)	Imaging assessments will be performed every 6 weeks until radiographically documented PD(Progressive Disease).	6 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: March 9, 2010
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): July 25, 2016

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Recurrence; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protective Agents; Antineoplastic Agents, Phytogenic; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Docetaxel; Paclitaxel; Cisplatin; Oxaliplatin; Leucovorin; Levoleucovorin
• Other Study ID Numbers: 4-2009-0596