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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01283204

Collaborator

(none)

180

Enrollment

Location

Arms

76.6

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent or Metastatic Gastric Cancer	Drug: SP Drug: FL/Tax Drug: FL/Doc Drug: FOLFOX	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 9, 2010

Actual Primary Completion Date :

Jul 25, 2016

Actual Study Completion Date :

Jul 25, 2016

Arms and Interventions

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 <Every 3 weeks> 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 <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 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 <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 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 <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 Other Names: Oxaliplatin with Leucovorin with 5-FU

Outcome Measures

Primary Outcome Measures

progression free survival(PFS) [6 weeks]
Imaging assessments will be performed every 6 weeks until radiographically documented PD(Progressive Disease).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.