A Prospective, Randomized, Phase 3 Trial of Carbon Ion Radiation Therapy Versus Standard Care for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall survival duration
研究概览
简要总结
This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 diagnosis of adenocarcinoma of the pancreas
- •Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0,
- •Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following:
- •major venous thrombosis of the portal vein or SMV extending for several centimeters (precluding vein resection and reconstruction) encasement (>180°) of the SMA or proximal hepatic artery abutment of the celiac trunk
- •No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
- •ECOG Performance Status 0-1 within 30 days prior to registration
- •CBC/differential obtained within 14 days prior to step 1 registration, with adequate bone marrow function defined as follows:
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- •Platelets ≥ 100,000 cells/mm3
- •Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
- •Additional laboratory studies within 14 days prior to registration demonstrating:
- •Creatinine < 2 mg/dl; GFR > 50 mL/min (Cockroft and Gault formula)
- •Bilirubin < 1.5 x ULN
- •ALT and AST ≤ 2.5 x ULN
- •aPTT, PT ≤ 1.5 x ULN
- •Patients must provide study specific informed consent prior to study entry.
- •Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration
排除标准
- •More than one primary lesion
- •Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
- •Active malignancy, other than pancreatic cancer, for which systemic therapy is indicated. -History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years is permitted.
- •Prior treatment for pancreatic cancer with surgical resection, external radiotherapy, or interstitial isotope implantation.
- •Prior treatment for pancreatic cancer with a systemic therapy regimen/agent not included in the list below. Systemic therapy must be discontinued at least 14 days before study enrollment.
- •FOLFIRINOX
- •Gemcitabine/nab-paclitaxel
- •Gemcitabine
- •Prior radiation therapy to the abdomen that would result in overlap of radiation therapy fields
研究组 & 干预措施
Carbon ion radiotherapy
Carbon ion radiotherapy will be administered 5 days each week (Monday-Friday). The prescription dose will be 60 GyE in 20 fractions, to be delivered over four weeks.
干预措施: carbon ion RT (Radiation)
Carbon ion radiotherapy
Carbon ion radiotherapy will be administered 5 days each week (Monday-Friday). The prescription dose will be 60 GyE in 20 fractions, to be delivered over four weeks.
干预措施: Chemotherapy drug (Drug)
Routine standard of care
Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.
干预措施: Chemotherapy drug (Drug)
结局指标
主要结局
Overall survival duration
时间窗: The length of time from randomization until death from any cause for up to 24 months
The length of time from randomization of treatment for cancer, that patients diagnosed with the disease are still alive.
次要结局
- Progression-free survival duration(he length of time from study registration until disease progression at any site or death from any cause, up to 24 months)
- Local disease progression scored using RECIST 1.1 criteria(Up to 24 months)
- Adverse events as defined by CTCAE v5.0(Up to 24 months)
- Quality-of-life, measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaire(up to 24 months)