The phase 2 study of neoadjuvant chemotherapy of GAS for biological borderline resectable pancreatic cancer.

JRCT ID: jRCTs061180009

Registered date:07/12/2018

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biological borderline resectable pancreatic cancer
• Date of first enrollment: 02/03/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Patients were assigned to the following levels of GAS regimens. Nab-paclitaxel was administered intravenously at 125 mg/m2, followed by intravenous gemcitabine at 1000 mg/m2. A daily dose of S1 was defined based on the patient's body surface area as follows:<1.25m2, 60mg;1.25-1.5m2,80mg;>1.5m2,100mg. S1 administered orally twice a day on days 1-7. The treatment cycle was repeated every 2 weeks. After 6 cycles of the GAS chemotherapy regimen, patients were reevaluated to assess resectability and response to the treatment.

Outcome(s)

• Primary Outcome: Two-year survival rate and median survival time after initiation of protocol therapy

Secondary Outcome

- Disease free survival after initiation of protocol therapy
- Adverse events
- Postoperative complication with more than grade 3
- Response rate and normalization rate of tumor markers after neoadjuvant chemotherapy
- Histological response (Evans grade)
- Curative resection rate
- Short time outcomes after surgical resection
- Reoperation rate, readmission rate and mortality
- Initiation and completion rate of adjuvant chemotherapy
- Dose intensity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(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 =<Normal upper limit x2.5, serum creatinine =<1.5mg/dl
(10)The willingness to sign a written informed consent before registration

Exclude criteria

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

Related Information

• Primary Sponsor: Uemura Kenichiro