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

NCT02817425 | Unknown Phase 2 DMC

• 1 other identifier: 2013078
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

S-1; Adjuvant Chemotherapy; TEGAFOX

Outcome Measures

Primary Outcomes (1)

• Overall Survial (OS)

  Event driven, an expected average of 48 months

Secondary Outcomes (3)

• Disease Free Survial

  Event driven, an expected average of 24 months

• 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

• Dose intensity

  Event driven, an expected average of 48 months

Study Arms (3)

SOX Sequential S-1 Group

ACTIVE COMPARATOR

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

Drug: SOX Sequential S-1

SOX Group

ACTIVE COMPARATOR

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

Drug: SOX

TEGAFOX Sequential S-1

EXPERIMENTAL

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

Drug: TEGAFOX Sequential S-1.

Interventions

SOX Sequential S-1 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 Sequential S-1 Group

SOX 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

SOX Group

TEGAFOX Sequential S-1. 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.

TEGAFOX Sequential S-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≧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

You may not qualify if:

• 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

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

Second Hospital Affiliated to Lanzhou University

Lanzhou, Gansu, 0931, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xiao Chen, MD

  Second Hospital Affiliated to Lanzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Chen, MD

CONTACT

+86 0931-8942318; chenxiaomd@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 29, 2016
• Study Start: May 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2019
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

CN (1)