Phase II Study of Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 22
- 主要终点
- R0 resection rate
研究概览
简要总结
Multicenter Prospective Phase II Study for Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
RATIONALE: Borderline resectable pancreatic cancer is frequently related to a positive surgical margin and has a poor prognosis after resection. Neoadjuvant chemoradiation with intensive local effect may lead to substantial local control and prolongation of survival in borderline resectable pancreatic cancer.
PURPOSE: This phase II trial assess efficacy and safety of neoadjuvant S-1 and concurrent radiotherapy for borderline resectable pancreatic cancer.
详细描述
S-1: S-1 is an oral fluorinated pyrimidine agent which contains tegafur (FT, a prodrug of 5-FU), 5-chloro-2,4-dihydropyrimidine (CHDP) and potassium oxonate (Oxo) effective for gastric and various other types of cancers. S-1 is also active for pancreatic cancer: S-1 demonstrated non-inferiority to gemcitabine in overall survival for metastatic or locally advanced pancreatic cancer (LAPC).
S-1 and Concurrent radiotherapy: S-1 therapy with concurrent radiation therapy (RT) had favorable activity with overall tumor response rate of 37%, as well as mild toxicity in patients with LAPC. The median survival time and the 2-year survival rate for LAPC patients treated by S-1/RT were 16.2 months and 26% respectively.
Definition of Borderline Resectable Pancreatic Cancer:(1) Reconstructible bilateral impingement of superior mesenteric vein or portal vein; (2) Tumor contact with the superior mesenteric artery (SMA) of </= 180 degrees ; (3) Tumor contact with the common hepatic artery of </= 180 degrees (at the root of the gastroduodenal artery); and (4) Tumor contact with the celiac axis of </= 180 degrees.
Tumor with portal vein tumor thrombus and tumor contact with the second or further jejunal SMA branch are considered as unresectable. Tumor which is contact with the common hepatic artery or celiac axis but can be resected by distal pancreatectomy with en bloc celiac axis resection, is not included in this study.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologic or histologic proof of pancreatic ductal carcinoma or adenosquamous carcinoma is required prior to study entry.
- •Disease assessment by Multi Detector-row Computed Tomography (MDCT) scan within 2 weeks of study entry
- •Borderline resectable pancreatic cancer
- •No evidence of metastatic disease as determined by chest CT scan, and abdominal CT scan and laparoscopy. Paraaortic lymph node metastasis is considered as metastatic.
- •Age >/=20 years old, </=75 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •No prior chemotherapy or radiotherapy for pancreatic cancer
- •A square 10 x 10 cm radiation field could encompass all pancreatic lesions and lymph node metastases
- •Adequate oral intake
- •Appropriate biliary drainage for obstructive jaundice
- •Lab Values:
- •hemoglobin concentration >/= 9.0 g/dL
- •leukocyte count >/= 3,000/mm3
- •platelet count >/= 100,000/mm3
- •serum total bilirubin </= 2.0 mg dL, or </=3.0 mg/dL with biliary drainage
- •Aspartate Transaminase (AST) and Alanine Transaminase (ALT) </= 100 U/L, or </= 150 U/L with biliary drainage
- •serum albumin >/= 3.0 g/dl
- •serum creatinine </= 1.2 mg dL
- •Creatinine clearance >/= 50 ml/min
- •Written informed consent
排除标准
- •Tumor invasion to the alimentary tract determined by abdominal CT scan or endoscopic examination
- •Prior chemotherapy using fluoropyrimidine
- •Prior radiation therapy to the abdomen
- •Watery diarrhea
- •Concurrent phenytoin, warfarin potassium, or flucytosine treatment
- •Presence of contrast medium allergy
- •Pulmonary fibrosis or interstitial pneumonia
- •Pleural effusion or ascites
- •Active infection
- •Uncontrolled diabetes mellitus (FBS >/= 200mg/dL or HbA1c >/= 10.0)
- •Active concomitant malignancy
- •Active gastroduodenal ulcer
- •Severe complications such as cardiac or renal disease
- •Regular administration of systemic corticosteroid
- •Psychiatric disorder
- •History of drug hypersensitivity
- •Pregnant and lactating women and women of childbearing age who were not using effective contraception
研究组 & 干预措施
Neoadjuvant S-1/RT
This is a single arm prospective study. All eligible subjects will receive neoadjuvant S-1 and concurrent radiation followed by surgical resection. Subjects may receive adjuvant chemotherapy after surgical resection at the clinical discretion of the medical oncologists.
干预措施: S-1 (Drug)
Neoadjuvant S-1/RT
This is a single arm prospective study. All eligible subjects will receive neoadjuvant S-1 and concurrent radiation followed by surgical resection. Subjects may receive adjuvant chemotherapy after surgical resection at the clinical discretion of the medical oncologists.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
R0 resection rate
时间窗: Up to 4 years
R0 resection rate of all patients enrolled in the study
次要结局
- Overall survival(up to 6 years)
- Surgical morbidity rates(With in 90 days)
- Response rate after neoadjuvant chemoradiation(Up to 4 years)
- Pathological response rate(Up to 4 years)
- Disease-free survival(up to 6 years)
- 2-year survival rate(up to 6 years)
- Acute and late toxicity rates(With in 6 months)
- R0 resection rate in borderline resectable pancreatic cancer(Up to 4 years)