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

Gastric Cancer Clinical Trial

Official title:

A Efficacy and Tolerability Study of Uracil/Ftorafur/Leucovorin Combined With Oxaliplatin (TEGAFOX) Sequential S-1 or SOX Sequential S-1 and S-1 Monotherapy in the Treatment of Adjuvant Chemotherapy for Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817425
• Other study ID #: 2013078
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 8, 2015
• Last updated: June 26, 2016
• Start date: May 2013
• Est. completion date: May 2019

Study information

• Verified date: June 2016
• Source: LanZhou University
• Contact: Xiao Chen, MD
• Phone: +86 0931-8942318
• Email: chenxiaomd[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 75?Age?18

• Histologically or cytologically confirmed gastrointestinal cancer

• Stage ? or ? or ?

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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.
• 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
• 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.

Locations

Country	Name	City	State
China	Second Hospital Affiliated to Lanzhou University	LanZhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
LanZhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survial (OS)		Event driven, an expected average of 48 months	No
Secondary	Disease Free Survial		Event driven, an expected average of 24 months	No
Secondary	Safety (Adverse Events)		Adverse events will be assessed at baseline (after the patients provided signed Informed Consent Form) until at least 4 weeks after the last dose of study drug was administered, an expected average of 3week	Yes
Secondary	Dose intensity	Dose intensity will be used for present patients' compliance	Event driven, an expected average of 48 months	No