Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

Study Description

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Brief Summary:

This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.

Condition or disease	Intervention/treatment	Phase
Resectable Pancreatic Carcinoma	Radiation: chemoradiotherapy with Gemcitabine; Radiation: Radiation: chemoradiotherapy with Gemcitabine	Phase 2

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 Design

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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

Arms and Interventions

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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.

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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.)
3. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
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

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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

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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
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