Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Sang-Jae Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01333124
First received: April 1, 2011
Last updated: October 17, 2013
Last verified: October 2013

April 1, 2011
October 17, 2013
April 2012
December 2013   (final data collection date for primary outcome measure)
Complete resection rate [ Time Frame: Within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).
Same as current
Complete list of historical versions of study NCT01333124 on ClinicalTrials.gov Archive Site
  • Clinical outcomes [ Time Frame: Up to 3years from a initial follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    To evaluate the feasibility and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of preoperative chemoradiotherapy with gemcitabine for resectable pancreatic cancer.
Same as current
Not Provided
Not Provided
 
Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Resectable Pancreatic Carcinoma
  • 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
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.
Interventions:
  • Radiation: chemoradiotherapy with Gemcitabine
  • Radiation: Radiation: chemoradiotherapy with Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
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
Korea, Republic of
 
NCT01333124
NCCCTS-10-500
No
Sang-Jae Park, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Sang-Jae Park, M.D. National Cancer Center, Korea
National Cancer Center, Korea
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP