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Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

This study is currently recruiting participants.
Verified September 2017 by Sang-Jae Park, National Cancer Center, Korea
Sponsor:
ClinicalTrials.gov Identifier:
NCT01333124
First Posted: April 11, 2011
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sang-Jae Park, National Cancer Center, Korea
  Purpose
This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.

Condition Intervention Phase
Resectable Pancreatic Carcinoma Radiation: chemoradiotherapy with Gemcitabine Radiation: Radiation: chemoradiotherapy with Gemcitabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

Resource links provided by NLM:


Further study details as provided by Sang-Jae Park, National Cancer Center, Korea:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Clinical outcomes [ Time Frame: Up to 3years from a initial follow-up ]
    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.

  • The association between biomolecular markers and clinical outcomes [ Time Frame: Up to 3years until study closed ]
    To investigate the association between biomolecular markers and clinical outcomes (including tumor response and complete resection rate, etc.)

  • The feasibility and compliance [ Time Frame: Up to 1 year ]
    To evaluate the feasibility and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of preoperative chemoradiotherapy with gemcitabine for resectable pancreatic cancer.


Estimated Enrollment: 64
Study Start Date: April 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Radiation: Radiation: chemoradiotherapy with Gemcitabine
Radiation: chemoradiotherapy with Gemcitabine

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333124


Contacts
Contact: Sang Jae Park, M.D +82-31-920-1640 spark@ncc.re.kr
Contact: Tae Hyun Kim, M. D. +82-31-920-1725 k2onco@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Sang-Jae Park, M.D.    +82-31-920-1640    spark@ncc.re.kr   
Contact: Tea Hyun Kim, M.D.    +82-31-920-1725    k2onco@ncc.re.kr   
Sub-Investigator: Tae Hyun Kim, M. D.         
Sub-Investigator: Sung Sik Han, M. D.         
Sub-Investigator: Sang Myeong Woo, M. D.         
Sub-Investigator: Woo Jin Lee, M. D.         
Sub-Investigator: Eun Kyeong Hong, M. D.         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Sang-Jae Park, M.D. National Cancer Center, Korea
  More Information

Responsible Party: Sang-Jae Park, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01333124     History of Changes
Other Study ID Numbers: NCCCTS-10-500
First Submitted: April 1, 2011
First Posted: April 11, 2011
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sang-Jae Park, National Cancer Center, Korea:
Preoperative chemoradiotherapy with Gemcitabine

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs


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