Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer
This study has been completed.
Sponsor:
Seoul National University Hospital
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
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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:
Detailed Description:
-
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
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:
- 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.
Contacts and Locations
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 Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013