Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma
Pancreatic Carcinoma Non-resectable
About this trial
This is an interventional treatment trial for Pancreatic Carcinoma Non-resectable
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the pancreas
- Unresectable locally advanced disease base on institutional standard criteria of unresectability disease following radical surgery. There is no evidence of metastatic disease in the major viscera and no peritoneal seeding
- Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation
- All malignant disease must be encompassable within a single irradiation field (15x15cm maximum)
- All patients must have radiographically assessable disease
- No previous irradiation to the planned field
- Age of ≥ 18 years
- performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) score
- Required Entry Laboratory Parameters WBC count ≥ 1,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decrease ≤ 3.0 mg/dL prior to study entry); creatinine ≤ 3.0 mg/dL
- Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.
- Signed informed consent form prior to study entry
Exclusion Criteria:
- There is evidence of metastasis in the major viscera or peritoneal seeding.
- Age of < 18 years
- Previous history of RT adjacent to planned field
- Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
- Pregnant or breast feeding status
- Previous history of uncontrolled other malignancies within 2 years
Sites / Locations
- National Cancer Center, Korea
Arms of the Study
Arm 1
Experimental
Induction chemotherapy followed by CCRT
In one cycle (4-weeks), gemcitabine 1,000 mg/m2 will be given by 30-minute intravenous infusion on days 1, 8, and 15, and 1 hour infusion of CDDP was administered at a dose of 25 mg/m2 weekly diluted in 500 mL of normal saline to ensure adequate hydration 1 hour before the administration of gemcitabine. Gemcitabine 300mg/m2 will be given by 30-minute intravenous infusion weekly during RT and CRT will be started within 3 weeks after completion of 2 cycles of induction chemotherapy. Radiotherapy - Total dose of PGTV and PCTV were 55 Gy, 22 fractions and 44 Gy, 22 fractions, respectively.