A Study of Locally Advanced Pancreatic Cancer

NCT01063192 | Unknown Phase 2 DMC

• 1 other identifier: T2209
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer. The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.

Conditions

Locally Advanced Pancreatic Cancer

Keywords

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.

  6 months

Secondary Outcomes (1)

• The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy .

  1 year

Study Arms (2)

Gemcitabine

ACTIVE COMPARATOR

Arm 1: Gemcitabine alone

Drug: Gemcitabine

GOFL

ACTIVE COMPARATOR

Arm 2: GOFL (Gem 800mg/m2 80min, Oxa 85mg/m2 2hr, 5FU 3000mg/m2, LV 150mg/m2 iv 48hr)

Drug: Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL)

Interventions

Gemcitabine DRUG

Arm 1: Gemcitabine alone on D1,8,15 every 28 days for 3 cycles

Gemcitabine

Gemcitabine, Oxaliplatin, 5-Fluorouracil, Leucovorin (GOFL) DRUG

Arm 2: GOFL on D1, 15 every 28 days for 3 cycles(Gem 800mg/m2 80min, Oxa 85mg/m2 2hr, 5FU 3000mg/m2, LV 150mg/m2 iv 48hr)

GOFL

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
• Patients must have locally advanced pancreatic cancer (LAPC).
• Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
• Patients must have measurable disease.
• Age \>20 years.
• ECOG performance scale of 0-2.
• Patients must have normal organ and marrow function.
• Patients who present with jaundice, temporary or permanent internal / external drainage before enrollment will be allowed.
• The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients with distant metastases are not eligible.
• Patients may not be receiving any other investigational agents.
• Patients who have had prior chemotherapy or radiotherapy are not eligible.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
• Patients who have above grade II peripheral neuropathy.
• Patients who had non-curable second primary malignancy.
• Uncontrolled intercurrent illness including.
• Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects.
• Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded from the study.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

MeSH Terms

Interventions

Gemcitabine; Oxaliplatin; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Pin-Wen Lin, M.D

  National Cheng-Kung University Hospital

  STUDY CHAIR

• Yen-Shen Shen, M.D.

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

• Chiun Hsu, Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: February 5, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2016
• Last Updated: February 5, 2010

Record last verified: 2010-02