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

Primary Purpose

Pancreatic Carcinoma Non-resectable

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Induction chemotherapy followed by CCRT
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Carcinoma Non-resectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Induction chemotherapy followed by CCRT

Arm Description

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.

Outcomes

Primary Outcome Measures

feasibility and compliance
to evaluate acute and late toxicity of induction chemotherapy with gemcitabine and cisplatin followed by chemoradiotherapy for unresectable pancreatic cancer.

Secondary Outcome Measures

overall survival
To evaluate the impact of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy
disease-free survival.
To investigate the association between tumor response of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy and clinical outcomes

Full Information

First Posted
May 1, 2012
Last Updated
January 1, 2018
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01593475
Brief Title
Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma
Official Title
A Phase II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Pancreatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 5, 2011 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Carcinoma Non-resectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction chemotherapy followed by CCRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Induction chemotherapy followed by CCRT
Intervention Description
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 Outcome Measure Information:
Title
feasibility and compliance
Description
to evaluate acute and late toxicity of induction chemotherapy with gemcitabine and cisplatin followed by chemoradiotherapy for unresectable pancreatic cancer.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
overall survival
Description
To evaluate the impact of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy
Time Frame
Up to 3years until study closed
Title
disease-free survival.
Description
To investigate the association between tumor response of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy and clinical outcomes
Time Frame
participants will be followed for the duration of disease free, an expected average of 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Jin Lee, Ph.D
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Korea
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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