Status:
UNKNOWN
Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer
Lead Sponsor:
Aiping Zhou
Conditions:
S-1 Plus Oxaliplatin
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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 recurr...
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 ox...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04694404
Start Date
May 11 2016
End Date
December 1 2022
Last Update
January 5 2021
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, China, 100021