Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01396681
First received: July 1, 2011
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine and cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • recurrence/metastasis free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2 year survival rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • recurrence free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Median recurrence free survival time

  • Safety and tolerability [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    patients who experienced grade 3-4 toxicity by RECIST criteria


Estimated Enrollment: 70
Study Start Date: December 2004
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396681

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Seock-Ah Im, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seock-Ah Im, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01396681     History of Changes
Other Study ID Numbers: H-0412-138-006
Study First Received: July 1, 2011
Last Updated: July 15, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
resected pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014