Clinical trial NCT04694404: Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer
Official title: The Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced or Recurrent Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: S-1 Plus Oxaliplatin
Keywords: S-1,Oxaliplatin,Advanced or Recurrent Gastric Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2021-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment Eledrly Patients with Untreated Advanced or Recurrent Gastric Cancer
Primary purpose: TREATMENT

Brief summary: Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.

Detailed description: 3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma;
* Aged≥60
* ability of oral administration;
* CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1);
* Untreated
* more than 12 months after the last adjuvant/neoadjuvant chemotherapy;
* ECOG=0-2;
* Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min
* Informed consent;
* Expected survival more than 3 months;More than 3 weeks after major surgery.

Exclusion Criteria:

* Neoadjuvant and/or adjuvant have been treated with more than two plans;
* In the past two years, the total dose of oxaliplatin≥800mg/m2;
* Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer;
* Symptomatic brain metastases or soft meningeal metastasis;
* Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure;
* Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃;
* Known allergy to drugs in the study;
* Pregnant or lactating women;
* Both male and female subjects of potential fertility have to agree effective birth control during the entire study;
* Experimental drugs used no more than 4 weeks;
* Other conditions the researchers considered ineligible for the study.

Primary outcomes:
measure: PFS
timeFrame: 6 months
Secondary outcomes:
measure: ORR
timeFrame: 6 months
measure: OS
timeFrame: 1 year
measure: The number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Aiping Zhou, Doctor
role: STUDY_DIRECTOR
References:
citation: Jiang Z, Zhou A, Sun Y, Zhang W. Biweekly oxaliplatin plus S1 for Chinese elderly patients with advanced gastric or gastroesophageal junction cancer as the first-line therapy: a single-arm, phase 2 study. BMC Cancer. 2022 Mar 9;22(1):253. doi: 10.1186/s12885-022-09332-7.