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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

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring resected pancreatic cancer

Eligibility Criteria

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

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

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

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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