Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
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ClinicalTrials.gov Identifier: NCT01333124 |
Recruitment Status
:
Recruiting
First Posted
: April 11, 2011
Last Update Posted
: September 14, 2017
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Condition or disease | Intervention/treatment | Phase |
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Resectable Pancreatic Carcinoma | Radiation: chemoradiotherapy with Gemcitabine Radiation: Radiation: chemoradiotherapy with Gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
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 |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2017 |

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.
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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
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- 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).
- 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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with resectable pancreatic adenocarcinoma
- Age over 18 years old and younger than 70 year old
- Performance status (ECOG scale): 0-1
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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
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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

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
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 | |
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. |
Principal Investigator: | Sang-Jae Park, M.D. | National Cancer Center, Korea |
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 Posted: | April 11, 2011 Key Record Dates |
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 |