ACTRN12619000409178招募中2 期
A Randomised Phase II Study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease (MASTERPLAN)
Australasian Gastro-Intestinal Trials Groups (AGITG)0 个研究点目标入组 120 人开始时间: 2019年3月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •*Adults, aged between 18-75 years, with pathologic confirmation of pancreatic adenocarcinoma
- •*Patients who are treatment-naïve, or have been commenced on chemotherapy less than or equal to 28 days prior to randomisation.
- •*Any of the following: T3 (tumour greater than 4 cm), Extrapancreatic extension, Node positive , Borderline resectable pancreatic cancer, locally advanced pancreatic cancer
- •*Measurable disease according to RECIST v1.1
- •*ECOG performance status 0-1
- •*Adequate renal and haematological function
- •*Adequate hepatic function. Defined as bilirubin less than 1.5 X ULN (Upper Limit of Normal), AST + ALT less than 3.0 X ULN. If a patient was recently stented with improving bilirubin, the patient can be randomised with bilirubin up to 3 x ULN provided chemotherapy is not administered until within the stated thresholds.
- •*Study treatment planned to start within 14 days of randomisation
- •*Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- •*Signed, written informed consent
排除标准
- •. Tumour size greater than 70mm
- •. Duodenal infiltration seen on endoscopy
- •. Prior abdominal radiotherapy,or previous radiation where the 5 Gy isodose line crosses into the treatment field (or an approximation of this if axial based imaging not utilised).
- •. Evidence of metastatic disease on baseline radiologic investigations
- •. History of another malignancy within 2 years prior to randomisation, except adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, -superficial transitional cell carcinoma of the bladder, any Stage 1 endometrial carcinoma, low risk prostate cancer with PSA less than or equal to 10 and Gleason score of less than or equal to 6 treated with any modality, including active surveillance-Patients with treated early-stage breast cancer on adjuvant endocrine therapy are eligible provided they have been disease free for at least 2 years after definitive treatment. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive treatment.
- •. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •. Neuroendocrine pancreatic carcinoma
- •. Life expectancy of less than 3 months
- •. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomisation. Men must use a reliable means of contraception
- •. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
研究者
相似试验
招募中
不适用
Phase 2 study of SBRT plus mFOLFIRINOX for locally advanced pancreatic cancerNeoplasmsKCT0005965Asan Medical Center92
已完成
2 期
Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer (JCOG1407, LAPC-mFOLFIRINOX/GnP-rP2)locally advanced pancreatic cancerJPRN-UMIN000023143Japan Clinical Oncology Group (JCOG)124
进行中（未招募）
1 期
_RAS and B-RAF wild-type metastatic colorectal cancer.MedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864EUCTR2016-001490-33-FRICANCER209
招募中
2 期
eoadjuvant FOLFIRINOXPancreatic cancer, Neoadjuvant therapyPancreatic cancerJPRN-jRCT1041220027Yamashita Tatsuya50
未知
2 期
A phase 2 trial of FOLFIRINOX in patients with previously untreated metastatic pancreatic cancerpreviously untreated pancreatic cancerJPRN-jRCT2080221426Yakult Honsha Co.,Ltd.35