Induction Chemotherapy With Gemcitabine And Cisplatin Followed By CCRT For Unresectable Pancreatic Carcinoma

Study Overview

Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma

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.

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.

Pancreatic Carcinoma Non-resectable

RADIATION: Induction chemotherapy followed by CCRT

NCCCTS-11-567

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-05-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-01-01
First Submitted that Met QC Criteria 2012-05-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-01-03
First Posted (ACTUAL) 2012-05-08	Results First Posted N/A	Last Verified 2018-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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	RADIATION: 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 adequ

Participant Group/Arm

Intervention/Treatment

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

RADIATION: 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 adequ

Primary Outcome Measures	Measure Description	Time Frame
feasibility and compliance	to evaluate acute and late toxicity of induction chemotherapy with gemcitabine and cisplatin followed by chemoradiotherapy for unresectable pancreatic cancer.	Up to 1 year

Secondary Outcome Measures	Measure Description	Time Frame
overall survival	To evaluate the impact of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy	Up to 3years until study closed
disease-free survival.	To investigate the association between tumor response of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy and clinical outcomes	participants will be followed for the duration of disease free, an expected average of 9 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Woo Jin Lee, Ph.D, National Cancer Center, Korea

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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