Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Margin-negative (R0) Resection Rate
研究概览
简要总结
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed completely.
详细描述
Investigators plan to conduct a prospective pilot phase II trial of GTX-SBRT as neoadjuvant treatment of borderline resectable pancreatic cancer. After informed consent, pretreatment pancreatic tumor tissues will be collected and immediately frozen at the time of staging endoscopic ultrasound (EUS). Ribonucleic acid (RNA) will be extracted from tumor specimens and run on microarray analysis to determine radiosensitivity index score. Borderline resectable (BR) patients will be treated with 3 cycles of GTX chemotherapy followed by SBRT. They will be restaged and evaluated for resectability 3 to 4 weeks later. Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery.
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
- •Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as:
- •circumferential tumor abutment with the superior mesenteric vein (SMV) or portal vein (PV) or SMV/PV confluence over </= 180°
- •circumferential tumor abutment with the superior mesenteric artery (SMA) over </= 180°
- •Short segment encasement (360°) of the PV or SMV that is amenable to partial vein resection and reconstruction
- •encasement of the gastroduodenal artery up to the origin of the hepatic artery
- •Patients must have measurable disease
- •No previous chemotherapy or radiation to the pancreas
- •Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%)
- •Patients must have normal organ and marrow function as defined below:
- •leukocytes >/= 3,000/μL
- •absolute neutrophil count >/= 1,000/ μL
- •platelets >/= 100,000/ μL
- •creatinine within normal institutional limits (ULN)
- •total bilirubin will allow for 2x the upper limit of the institution. Patients may have biliary stents or drains to lower total bilirubin to this range.
- •Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential). Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients with metastatic disease are ineligible.
- •Patients who have had prior chemotherapy for pancreatic adenocarcinoma
- •Patients who have received prior radiation to an abdominal site are not eligible.
- •Patients with peripheral neuropathy >/= grade 2
- •Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel), other drugs formulated with polysorbate 80, gemcitabine, or capecitabine
- •Patients may not be receiving any other investigational agents.
- •ECOG Performance Status 3-4
- •Pregnant or breast-feeding women are excluded from this study because gemcitabine,capecitabine, and docetaxel are Class D agents with the potential for teratogenic or abortifacient effects.
- •Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.
研究组 & 干预措施
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
干预措施: Capecitabine (Drug)
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
干预措施: Gemcitabine (Drug)
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
干预措施: Docetaxel (Drug)
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
干预措施: Stereotactic body radiation therapy (SBRT) (Radiation)
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
干预措施: Restaging review after radiation (Other)
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
干预措施: Surgery (Procedure)
Chemotherapy Followed by Radiation Treatment
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).
After radiation, participants will be re-evaluated for surgery.
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Margin-negative (R0) Resection Rate
时间窗: Up to 3 years
R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.
次要结局
- Overall Survival (OS) Rate(12 months)
- Progression-Free Survival (PFS) at Three Years(3 years)