Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396681
• Other study ID #: H-0412-138-006
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2011
• Last updated: July 15, 2011
• Start date: December 2004
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine and cisplatin
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence/metastasis free survival		24 months	No
Secondary	2 year survival rate		24 months	No
Secondary	Overall survival		24 months	No
Secondary	recurrence free survival	Median recurrence free survival time	24 months	No
Secondary	Safety and tolerability	patients who experienced grade 3-4 toxicity by RECIST criteria	24 months	Yes