Clinical trial NCT02817425: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Keywords: S-1
Adjuvant Chemotherapy
TEGAFOX
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Survial (OS)
timeFrame: Event driven, an expected average of 48 months
Secondary outcomes:
measure: Disease Free Survial
timeFrame: Event driven, an expected average of 24 months
measure: Safety (Adverse Events)
timeFrame: 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
measure: Dose intensity
timeFrame: Event driven, an expected average of 48 months
Other outcomes:
Locations:
city: LanZhou
country: China
facility: Second Hospital Affiliated to Lanzhou University
state: Gansu
Study officials:
affiliation: Second Hospital Affiliated to Lanzhou University
name: Xiao Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: