A phase II study of preoperative DOS for cStage III gastric cancer
- Conditions
- Gastric cancer
- Registration Number
- JPRN-jRCTs051180086
- Lead Sponsor
- Kurokawa Yukinori
- Brief Summary
The primary endpoint, the 3-year progression-free survival rate, was 54.2% (80% CI, 52.2%-70.8%; 95% CI, 41.8%-70.3%), and the lower limit of the 80% confidence interval exceeded the 50% threshold. This showed a statistically significant difference. There were no major safety issues, and preoperative DOS therapy was considered to be a promising treatment regimen for cStage III gastric cancer and esophagogastric junction cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
1) Histological proven adenocarcinoma.
2) cStage III gastric or esophagogastric junction cancer.
3) Not Borrmann type 4 and not large (8cm or less) type 3.
4) Possible for R0 surgery.
5) No prior treatment of chemotherapy or radiation therapy and no history of surgery for gastric cancer.
6) No active gastrointestinal bleeding.
7) Possible oral intake or administration of adequate calories using an enteral feeding tube.
8) ECOG performance status of 0 or 1.
9) Aged 20 to 79 years old.
10) No prior treatment of chemotherapy, radiation or hormone therapy against any other malignancies.
11) No history of gastrectomy other than endoscopic mucosal resection.
12) Adequate organ function.
13) Written informed consent from patient.
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Past history of severe hypersensitivity to drugs.
3) Active infection.
4) Severe complications (interstitial pneumonia, pulmonary fibrosis, renal failure, liver failure, heart failure, uncontrollable diabetes millutus and Uncontrollable hypertension)
5) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason.
6) Edema of limbs and trunk by any reason.
7) Continuous systemic steroid therapy.
8) Under treatment with flucytosine, phenytoin, or warfarin.
9) Abnormal electrocardiogram or severe cardiovascular disease.
10) Severe diarrhea.
11) Positive HBs antigen.
12) Pregnant women, or women with the possibility of the pregnancy and men who want let to pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival
- Secondary Outcome Measures
Name Time Method overall survival, response rate, pathological response rate, R-0 resection rate, adverse event rate