Chemoradiation therapy on conversion surgery for unresectable locally advanced pancreatic cancer

JRCT ID: jRCTs051210167

Registered date:03/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic ductal adenocarcinoma
• Date of first enrollment: 03/02/2022
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Group suegery
surgery

Group Post-chemotherapy surgery
GEM;800mg/m2,intravenous infusion on Day1,Da
y8,Day15,Day29
nab-PTX;100mg,intravenous infusion on Day1,Da
y8,Day15,Day29
RT;2.0 Gy/day,from Monday to Friday every week,
total 50.0 Gy
surgery

Outcome(s)

• Primary Outcome: Overall survival (OS)
• Secondary Outcome: Progression-free survival (PFS), The rate of R0 resection, The rate of perioperative complications, The effect of chemoradiotherapy, The site of recurrence, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inclusion criteria
(1) Histological or cytological evidence of pancreatic ductal carcinoma
(2) Age>=20
(3) PS:0-1(ECOG grade)
(4) Patients with unresectable locally advanced pancreatic ductal carcinoma at the first visit, which are diagnosed as being able to undergo conversion surgery after Gemcitabine+nab-paclitaxel therapy

The criteria of unresectable locally advanced cancer
1)Solid tumor contact with the SMA or CA > 180deg
2)Solid tumor contact with the CA and aortic involvement
3)Unreconstructible SMV/PV due to tumor involvement or occlusion

The criteria of conversion surgery
1) The serum tumor marker (CEA, CA19-9) is within normal range
2) Imagings of computed tomography (less than 5mm slice) meet the following criteria
i) no metastasis
ii) No tumor contact with the SMV or PV.
Solid tumor contact with the SMV or PV with suitable vessel proximal and distal to the site of involvement allowing for safe and complete resection and vein reconstruction
iii) In pancreatic head/uncinate, no arterial tumor contact (CA, SMA, CHA). Solid tumor contact with CHA without extension to CA or hepatic artery bifurcation allowing for safe and complete resection and reconstruction. Solid tumor contact with the SMA of <180deg
iv) In the pancreatic body/tail, solid tumor contact with the CA of <180deg. Solid tumor with the CA of >180deg without the involvement of aorta and with intact and uninvolved
Even if the above criteria are not met, conversion surgery is possible when there is no abnormal accumulation of FDG at PET-CT, or at biopsy there are not malignant findings, conversion surgery was possible.

(5) Patients with the normal function of principle organs (bone marrow, liver, kidney, lung, etc)
Leukocyte >=3,500/mm3
Neutrocyte >=2,000/mm3
Platelet >=100,000/mm3
Hemogrobin >=9.0g/dl
Total bilirbin <=2.0mg/dl (or <=3.0mg/dl in patients with intervention for obstruction jaundice)
AST (GOT), ALT (GPT)<=150U/L
Serum creatinine <=1.5mg/dl
Creatinine clearance >=60ml/min (according to Cockroft-Gault calculating formula)
(6) Acquisition of written informed consent

Exclude criteria

Exclusion criteria
(1) Unresectable pancreatic ductal carcinoma with the following imaging criteria
1)no distant metastasis
2)no peritoneal dissemination, positive cytology
3)no para-aortic lymph node metastasis
(2) Patients with tumor involvement in organs that are difficult to treat with radiation
(3) Patients with anamnesis of pulmonary fibrosis or emphysema, or patients with severe respiratory d disability
(for example,%VC<=50% or FW|EV1.0<1L)
(4) Patients with active infection except for viral hepatitis
(5) Patients with severe general complications, for example, cardiac failure, renal failure, hepatic failure,
uncontrolled diabetes, etc.
(6) Patients with a moderate amount of ascites or pleural effusion
(7)Patients with active double cancer (synchronous or metachronous with a disease-free period of 3 years or less)
(8) Patients in pregnancy, patients in possible pregnancy, patients which wish to be in pregnancy, patients with breastfeeding, a male which wishes that his partner is to be in pregnancy
(9) Patients with severe mental disability
(10) Patients with severe drug-induced hypersensitivity syndrome
(11) Patients who are judged inappropriate for entry into this study by the investigators

Related Information

• Primary Sponsor: Kobayashi Shogo