Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gemcitabine and cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring resected pancreatic cancer
Eligibility Criteria
Inclusion Criteria:
- Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- Be between 18 and 75 years of age.
- Patients who are ambulatory and have a ECOG Performance Status of 0-2.
- Histologically confirmed pancreatic adenocarcinoma.
- Received curative resection (R0 resection) of stage 1b ~ 2b pancreatic cancer (according to AJCC staging, 6th edition - Appendix 1), no more than 8 weeks has elapsed since the time of operation.
- WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3. Platelet count at least 100,000/mm3.
- Bilirubin less than 2.0 mg/dL, AST less than 3 times upper limit of normal (ULN).
Serum creatinine no greater than 1.5 times ULN.
Exclusion Criteria:
- Pregnant or lactating woman.
- Woman of childbearing potential with either a positive or no pregnancy test at baseline.
- Woman of childbearing potential not using a reliable and appropriate contraceptive method (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Sexually active males unwilling to practice contraception during the study.
- Prior chemotherapy for the treatment of pancreatic carcinoma.
- Radiotherapy incorporating radiation fields of more than 25% of active bone marrow.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication).
- Participation in any investigational drug study within four weeks preceding the start of study treatment.
- Serious, uncontrolled, intercurrent infection(s).
- Other significant medical conditions that would, in the judgment of the investigator, make administration of study drug unsafe.
Sites / Locations
- Seoul National University Bundang Hospital
- Seoul National University Hospital
Outcomes
Primary Outcome Measures
recurrence/metastasis free survival
Secondary Outcome Measures
2 year survival rate
Overall survival
recurrence free survival
Median recurrence free survival time
Safety and tolerability
patients who experienced grade 3-4 toxicity by RECIST criteria
Full Information
NCT ID
NCT01396681
First Posted
July 1, 2011
Last Updated
July 15, 2011
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01396681
Brief Title
Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer
Official Title
Phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.
Detailed Description
The primary study objective is to evaluate recurrence/metastasis free survival at 12 months with postoperative adjuvant treatment incorporating gemcitabine plus cisplatin chemotherapy followed by chemoradiation with gemcitabine followed by maintenance chemotherapy with gemcitabine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
resected pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gemcitabine and cisplatin
Intervention Description
The study consists of three phases; Induction chemotherapy phase:Starting 4~8 weeks after R0 resection of pancreatic cancer. Gemcitabine: 1200mg/㎡ (Day 1, 8), cisplatin 60mg/㎡ (Day 1) every 3 weeks for 2 cycles. Chemoradiotherapy phase: Starting 1-2 weeks after completion of induction chemotherapy (within 5 weeks after D1 of 2nd cycle of induction chemotherapy), no later than 16 weeks after operation. Gemcitabine 300mg/㎡ weekly for 5 weeks throughout RT period. Radiotherapy: 50.4Gy at 1.8Gy/Fx, for 28 Fx (Field reduction at 45Gy) for 5.5 pweeks. Maintenance chemotherapy phase: Within 4 weeks after completion of chemoradiotheray, no later than 6 weeks after completion of chemoradiotherapy Gemcitabine: 1200mg/㎡ (Day 1, 8) every 3 weeks, for 4 cycles
Primary Outcome Measure Information:
Title
recurrence/metastasis free survival
Time Frame
24 months
Secondary Outcome Measure Information:
Title
2 year survival rate
Time Frame
24 months
Title
Overall survival
Time Frame
24 months
Title
recurrence free survival
Description
Median recurrence free survival time
Time Frame
24 months
Title
Safety and tolerability
Description
patients who experienced grade 3-4 toxicity by RECIST criteria
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Be between 18 and 75 years of age.
Patients who are ambulatory and have a ECOG Performance Status of 0-2.
Histologically confirmed pancreatic adenocarcinoma.
Received curative resection (R0 resection) of stage 1b ~ 2b pancreatic cancer (according to AJCC staging, 6th edition - Appendix 1), no more than 8 weeks has elapsed since the time of operation.
WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3. Platelet count at least 100,000/mm3.
Bilirubin less than 2.0 mg/dL, AST less than 3 times upper limit of normal (ULN).
Serum creatinine no greater than 1.5 times ULN.
Exclusion Criteria:
Pregnant or lactating woman.
Woman of childbearing potential with either a positive or no pregnancy test at baseline.
Woman of childbearing potential not using a reliable and appropriate contraceptive method (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
Sexually active males unwilling to practice contraception during the study.
Prior chemotherapy for the treatment of pancreatic carcinoma.
Radiotherapy incorporating radiation fields of more than 25% of active bone marrow.
History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication).
Participation in any investigational drug study within four weeks preceding the start of study treatment.
Serious, uncontrolled, intercurrent infection(s).
Other significant medical conditions that would, in the judgment of the investigator, make administration of study drug unsafe.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seock-Ah Im, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer
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