Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma
Conditions
Pancreatic Carcinoma Non-resectable
Conditions: official terms
Carcinoma - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Induction chemotherapy followed by CCRT
Type: Radiation
Overall Status
Recruiting
Summary
This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer patients with locally advanced disease and the purpose of this trial is to evaluate the efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable pancreatic carcinoma.
Detailed Description
The primary endpoint is feasibility and compliance of induction chemotherapy with gemcitabine and cisplatin followed by CRT for locally advanced unresectable pancreatic cancer. Previous studies showed that approximately 20% of patients with locally advanced disease developed the early distant metastasis.[6, 7] Thus, it will be expected that at least 80% of total patients will be eligible for induction chemotherapy after completion of induction chemotherapy. An experimental arm that result a compliance of 80% would merit further study. If the true compliance rate of the patients who will eligible for CRT is ≤ 60%, null hypothesis will be rejected with a power of 80% and a type I error of 5%. Thus, the required number of evaluable patients is 24. Considering the 10% follow-up loss and 20% distant metastasis rate after induction chemotherapy, a total of 34 eligible patients will be enrolled.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Tea Hyun Kim, Ph.D - +82-31-920-1725 - k2onco@ncc.re.kr
Start Date
March 2012
Completion Date
August 2015
Sponsors
National Cancer Center, Korea
Source
National Cancer Center, Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page