Induction Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma A Prospective Evaluation in Patients With Locally Advanced Pancreas Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Local Progression-free Survival (LPFS)
研究概览
简要总结
The current study seeks to further investigate the impact of up-front systemic therapy in combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic adenocarcinoma.
详细描述
All subjects will have a baseline CT or FDG-PET/CT prior to initiation of therapy. This will be done at the Hillman or in Radiation Oncology. Enrolled patients will undergo appropriate lab work and staging as described
- Albumin, alkaline phosphatase, glucose, electrolytes
- Ca 19-9 and CEA
- Due to an interaction of capecitabine and oral coumadin-derivative anticoagulants and risk of bleeding/thrombotic events, if a patient is on coumadin, frequent monitoring of INR and dose adjustments of anticoagulants must be exercised during protocol treatment. Alternatively, low molecular weight heparin may be substituted for oral anticoagulants Chemotherapy will be initiated consisting of gemcitabine 1000mg/m2 IV on day 1 and 8 of a 21 day cycle. Dosage for gemcitabine is described below using the Body surface area (BSA).
BSA will be calculated from body weight in kg, recorded prior to every gemcitabine dosing, and height in cm, recorded at baseline.
Premedication for Gemcitabine
A standard, FDA-approved antiemetic medication will be administered to study participants at the discretion of the treating oncologist (investigator) one-half hour prior to the gemcitabine infusion. Examples of standard antiemetics include ondansetron (Zofran), granisetron (Kytril), dolasetron (Anzemet), compazine, and dexamethasone. The dosage and route of administration will be determined by the treating oncologist based upon the given clinical scenario.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven adenocarcinoma of the pancreas
- •Subjects will be staged according to the 2010 AJCC staging system with pathologic stage T1-4, N0-1 being eligible; and have a primary tumor of the pancreas (i.e., pancreatic head, neck, uncinate process, body/tail
- •Tumor must be deemed to be borderline resectable or locally advanced by radiographic criteria defined by Varadhachary et al.26 Final CT confirmation of surgical staging/eligibility will be by two expert pancreatic surgeons
- •Disease confined to locoregional site confirmed by FDG-PET/CT or CT and diagnostic staging laparoscopy to ensure no occult peritoneal implants
- •Disease must be encompassed in a reasonable SBRT "portal" as defined by the treating radiation oncologist
- •Measurable disease on imaging studies (MRI, CT, FDG-PET/CT or physical exam), including maximum diameter/dimension, must be present for assessment of response
- •Karnofsky performance status > 70 (ECOG 0-1)
- •Age > 18
- •Estimated life expectancy > 12 weeks
- •Patient must have adequate renal function as defined by serum creatinine<1.5mg/dl obtained within 28 days prior to registration
- •Patient must have adequate bone marrow function as defined by absolute neutrophil count>1500/mcl and platelets>100,000/mcl, obtained within 28 days prior to registration
- •Patient must have adequate hepatic function as defined by total bilirubin <1.5 x IULN(institutional upper limit of normal) and either SGOT or SGPT <2.5x IULN, obtained within 28 days prior to registration.
- •Patient must be able to swallow enteral medications. Patient must not require a feeding tube. Patient must not have intractable nausea or vomiting, GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, or uncontrolled inflammatory bowel disease (Chron's, ulcerative colitis).
- •Diabetes must be controlled prior to FDG-PET/CT scanning (blood glucose <200 mg/dL)
- •Ability to provide written informed consent
- •Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of myocardial infarction or cerebrovascular accident within 3 months prior to registration, uncontrolled diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patient must not be pregnant because of the risk of harm to the fetus. Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen. Women/men of reproductive potential must agree to use an effective contraception method.
排除标准
- •Non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas are not eligible.
- •Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
- •Subjects with recurrent disease
- •Prior radiation therapy to the upper abdomen or liver
- •Prior chemotherapy
- •Subjects in their reproductive age group should use an effective method of birth control. Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study
- •Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
- •Concurrent serious infection
- •Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ, adequately treated basal cell or squamous cell carcinoma of the skin, and treated low-risk prostate cancer.
研究组 & 干预措施
Gem, Xeloda, SBRT
干预措施: Gemcitabine (Drug)
Gem, Xeloda, SBRT
干预措施: Capecitabine (Drug)
Gem, Xeloda, SBRT
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
结局指标
主要结局
Local Progression-free Survival (LPFS)
时间窗: Up to 32 months
LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume. Death or development of distant disease is not regarded as an event. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, progressive disease is defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started.
次要结局
- Objective Response Rate (ORR) (Surgery After Chemotherapy and SBRT)(Up to 24 months)
- Overall Survival (OS)(Up to 32 months)
- The Functional Assessment of Cancer Therapy - General (FACT-G)(Baseline; 2 - 4 weeks post chemotherapy; 4-6 weeks post SBRT; after surgery (up to 24 months))
- Number of Participants Able to Undergo a Margin-negative Resection After Neoadjuvant Therapy(Up to 24 months)
- Acute Toxicities Associated With SBRT(Up to 3 months following SBRT treatment)
- Late Toxicities Associated With SBRT(From 3 months following SBRT treatment up to 24 months)
- Role of FDG-PET/CT(Up to 24 months)
- Objective Response Rate (ORR) (Neoadjuvant Chemotherapy)(Up to 24 months)
- Time to Progression (TTP)(Up to 5 years)
研究者
David A. Clump, MD, PhD
Assistant Professor, Radiation Oncology
University of Pittsburgh