Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer

NCT01396681 | Completed Phase 2

• 1 other identifier: H-0412-138-006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer

Keywords

resected pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• recurrence/metastasis free survival

  24 months

Secondary Outcomes (4)

• 2 year survival rate

  24 months

• Overall survival

  24 months

• recurrence free survival

  24 months

• Safety and tolerability

  24 months

Interventions

gemcitabine and cisplatin DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Seock-Ah Im, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 19, 2011
• Study Start: December 1, 2004
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 19, 2011

Record last verified: 2011-07

Locations

KR (2)