- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01333124
Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
April 2, 2020 updated by: Sang-Jae Park, National Cancer Center, Korea
A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery.
An experimental arm that result a complete resection rate of at least 90% would merit further study.
With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required.
Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republic of
- National Cancer Center, Korea
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with resectable pancreatic adenocarcinoma
- Age over 18 years old and younger than 70 year old
- Performance status (ECOG scale): 0-1
Adequate organ functions
- Hb ≥9.0 g/dl
- ANC ≥1,500/mm3
- PLT ≥100,000/mm3
- Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
- Creatinine ≤1.5 ULN
- Patients should sign a written informed consent before study entry.
Exclusion Criteria:
- Tumor type other than adenocarcinoma
- Unresectable for resection on preoperative evaluation
- Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
- Prior radiotherapy
- Major surgery within 4 weeks prior to study treatment
Serious illness or medical conditions, as follows;
- congestive heart failure (NYHA class III or IV)
- unstable angina or myocardial infarction within the past 6 months,
- significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- uncontrolled hypertension
- hepatic cirrhosis( ≥ Child class B)
- interstitial pneumonia, pulmonary adenomatosis
- psychiatric disorder that may interfere with and/or protocol compliance
- unstable diabetes mellitus
- uncontrolled ascites or pleural effusion
- active infection
- Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiation: chemoradiotherapy with Gemcitabine
Radiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA.
If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks.
After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days.
Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.
|
All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA.
If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks.
After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days.
Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.
Radiation: chemoradiotherapy with Gemcitabine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete resection rate
Time Frame: Within the first 30 days after surgery
|
To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).
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Within the first 30 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcomes
Time Frame: Up to 3years from a initial follow-up
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To investigate the association between radiologic, histopathologic response, complete resection rate of preoperative chemoradiotherapy with gemcitabine and clinical outcomes, such overall survival and disease-free survival.
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Up to 3years from a initial follow-up
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The association between biomolecular markers and clinical outcomes
Time Frame: Up to 3years until study closed
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To investigate the association between biomolecular markers and clinical outcomes (including tumor response and complete resection rate, etc.)
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Up to 3years until study closed
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The feasibility and compliance
Time Frame: Up to 1 year
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To evaluate the feasibility and compliance (acute and late toxicity, esp.
gastrointestinal tract toxicity) of preoperative chemoradiotherapy with gemcitabine for resectable pancreatic cancer.
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sang-Jae Park, M.D., National Cancer Center, Korea
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2011
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
April 1, 2011
First Submitted That Met QC Criteria
April 8, 2011
First Posted (Estimate)
April 11, 2011
Study Record Updates
Last Update Posted (Actual)
April 6, 2020
Last Update Submitted That Met QC Criteria
April 2, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Carcinoma
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- NCCCTS-10-500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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