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

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

SOX Sequential S-1

SOX

TEGAFOX Sequential S-1.

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring S-1, Adjuvant Chemotherapy, TEGAFOX

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Second Hospital Affiliated to Lanzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

SOX Sequential S-1 Group

SOX Group

TEGAFOX Sequential S-1

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Overall Survial (OS)

Secondary Outcome Measures

Disease Free Survial

Safety (Adverse Events)

Dose intensity

Dose intensity will be used for present patients' compliance

Full Information

NCT ID

NCT02817425

First Posted

June 8, 2015

Last Updated

June 26, 2016

Sponsor

LanZhou University

1. Study Identification

Unique Protocol Identification Number

NCT02817425

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

LanZhou University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

S-1, Adjuvant Chemotherapy, TEGAFOX

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SOX Sequential S-1 Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

SOX Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

TEGAFOX Sequential S-1

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SOX Sequential S-1

Intervention Description

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

Intervention Name(s)

SOX

Intervention Description

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

Intervention Name(s)

TEGAFOX Sequential S-1.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Survial (OS)

Time Frame

Event driven, an expected average of 48 months

Secondary Outcome Measure Information:

Title

Disease Free Survial

Time Frame

Event driven, an expected average of 24 months

Title

Safety (Adverse Events)

Time Frame

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

Title

Dose intensity

Description

Dose intensity will be used for present patients' compliance

Time Frame

Event driven, an expected average of 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao Chen, MD

Phone

+86 0931-8942318

chenxiaomd@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiao Chen, MD

Organizational Affiliation

Second Hospital Affiliated to Lanzhou University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Second Hospital Affiliated to Lanzhou University

City

LanZhou

State/Province

Gansu

ZIP/Postal Code

0931

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

WEN QIU

Phone

0931-8487117

qiuwenmm@sina.com

First Name & Middle Initial & Last Name & Degree

XIAO CHEN, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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