A Efficacy and Tolerability Study of TEGAFOX Sequential S-1 in the Treatment of Adjuvant Chemotherapy for Gastric Cancer

NCT ID: NCT02817425

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2019-05-31

Brief Summary

This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOX Sequential S-1 Group

Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months

Group Type: ACTIVE_COMPARATOR

SOX Sequential S-1

Intervention Type: DRUG

8 cycles SOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1.Every 21 days as a cycle.

SOX Group

Patients received chemotherapy with" oxaliplatin+ S-1 " for 12 months

Group Type: ACTIVE_COMPARATOR

SOX

Intervention Type: DRUG

S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. Every 21 days as a cycle

TEGAFOX Sequential S-1

Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months

Group Type: EXPERIMENTAL

TEGAFOX Sequential S-1.

Intervention Type: DRUG

6 cycles TEGAFOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. TF 1000 mg/m2 with calcium folinate 300 mg/m2 IV infusion from Day 1 to Day 5 Every 28 days as a cycle.

Interventions

SOX Sequential S-1

8 cycles SOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1.Every 21 days as a cycle.

Intervention Type: DRUG

SOX

S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. Every 21 days as a cycle

Intervention Type: DRUG

TEGAFOX Sequential S-1.

6 cycles TEGAFOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. TF 1000 mg/m2 with calcium folinate 300 mg/m2 IV infusion from Day 1 to Day 5 Every 28 days as a cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 75≧Age≧18
• Histologically or cytologically confirmed gastrointestinal cancer
• Stage Ⅱ or Ⅲ or Ⅳ
• ECOG ≦2
• Accept the gastric cancer radical resection
• Life expectancy of at least three months
• Written informed consent to participate in the trial

Exclusion Criteria

• History of severe hypersensitivity reactions to the ingredients of S-1\TF\5-FU/calcium folinate or oxaliplatin
• Inadequate hematopoietic function which is defined as below:

• white blood cell (WBC) less than 5x10^9/L
• absolute neutrophil count (ANC) less than 2x10^9/L
• platelets less than 100*10^9/L
• Inadequate hepatic or renal function which is defined as below:

• serum bilirubin greater than 2 times the upper limit of normal range
• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
• blood creatinine level greater than 2 times ULN
• Presence of peripheral neuropathy
• Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
• Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
• Psychiatric disorder or symptom that makes participation of the patient difficult;
• Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months
• Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: lead

Responsible Party

Xiao Chen, MD

Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Second Hospital Affiliated to Lanzhou University

Locations

Second Hospital Affiliated to Lanzhou University

Lanzhou, Gansu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao Chen, MD

Role: CONTACT

chenxiaomd@163.com

+86 0931-8942318

Facility Contacts

WEN QIU

Role: primary

qiuwenmm@sina.com

0931-8487117

Other Identifiers

2013078

Identifier Type: -

Identifier Source: org_study_id