Overview

This trial is active, not recruiting.

Condition pancreatic carcinoma non-resectable
Treatment induction chemotherapy followed by ccrt
Phase phase 2
Sponsor National Cancer Center, Korea
Start date March 2012
End date August 2017
Trial size 34 participants
Trial identifier NCT01593475, NCCCTS-11-567

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
induction chemotherapy followed by ccrt
Chemotherapy 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 CCRT 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.

Primary Outcomes

Measure
feasibility and compliance
time frame: Up to 1 year

Secondary Outcomes

Measure
overall survival
time frame: Up to 3years until study closed
disease-free survival.
time frame: participants will be followed for the duration of disease free, an expected average of 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Pancreatic Carcinoma
Principal investigator Woo Jin Lee, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by National Cancer Center, Korea.