Clinical trial NCT01396681: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: resected pancreatic cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Be between 18 and 75 years of age.
3. Patients who are ambulatory and have a ECOG Performance Status of 0-2.
4. Histologically confirmed pancreatic adenocarcinoma.
5. 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.
6. WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3. Platelet count at least 100,000/mm3.
7. 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:

1. Pregnant or lactating woman.
2. Woman of childbearing potential with either a positive or no pregnancy test at baseline.
3. 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).
4. Sexually active males unwilling to practice contraception during the study.
5. Prior chemotherapy for the treatment of pancreatic carcinoma.
6. Radiotherapy incorporating radiation fields of more than 25% of active bone marrow.
7. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
8. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication).
9. Participation in any investigational drug study within four weeks preceding the start of study treatment.
10. Serious, uncontrolled, intercurrent infection(s).
11. Other significant medical conditions that would, in the judgment of the investigator, make administration of study drug unsafe.

Primary outcomes:
measure: recurrence/metastasis free survival
timeFrame: 24 months
Secondary outcomes:
measure: 2 year survival rate
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: recurrence free survival
timeFrame: 24 months
measure: Safety and tolerability
timeFrame: 24 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seock-Ah Im, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: