The phase 2 study of neoadjuvant chemotherapy of GAS for biological borderline resectable pancreatic cancer.
- Conditions
- Biological borderline resectable pancreatic cancer
- Registration Number
- JPRN-jRCTs061180009
- Lead Sponsor
- emura Kenichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
(1) A histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma
(2) No distant metastasis
(3) Tumor with no contact with the major arteries including the superior mesenteric artery, celiac artery, or common hepatic artery on pretreatment computed tomography (CT)
(4) Tumor with no contact or less than 180 degrees contact with portal vein
(5) More than 100 U/ml of pretreatment serum CA19-9 level
(6) Initial treatment
(7) 0 or 1 of Performance status (ECOG)
(8) Age between 20 and 79
(9) Adequate hematological, hepatic, and renal functions by hemoglobin >=9.0 g/dl, leucocytes >=3,000 /mm2 and =<12,000 /mm2, neutrophils >=1,500 /mm2, platelets >=100,000 /mm2, total bilirubin =<2.0mg/dl, aspartate aminotransferase and alanine aminotransferase =(10)The willingness to sign a written informed consent before registration
1.Severe allergy for protocol drugs
2.History of active malignant disease within 5 years
3.Active infectious disease
4.More than Grade2 of neuropathy
5.Ileus
6.Active interstitional pneumonia
7.Uncontrolable ascites and pleural effusion
8.Uncontrolable diabetes
9.Uncontrolable heart diseases
10.History of sevese neurological diseases
11.Severe diarrhea
12.Pregnancy or possibility of pregnancy
13.Others who were judged to be not appreciated for participation to this clinical trial by attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year survival rate and median survival time after initiation of protocol therapy
- Secondary Outcome Measures
Name Time Method - Disease free survival after initiation of protocol therapy <br>- Adverse events <br>- Postoperative complication with more than grade 3 <br>- Response rate and normalization rate of tumor markers after neoadjuvant chemotherapy <br>- Histological response (Evans grade) <br>- Curative resection rate <br>- Short time outcomes after surgical resection <br>- Reoperation rate, readmission rate and mortality <br>- Initiation and completion rate of adjuvant chemotherapy <br>- Dose intensity