Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 12
- 主要终点
- The rate of 14-EISCP success
研究概览
简要总结
This study assessed the feasibility and effects of an early integrative supportive care program in patient with advanced pancreatic adenocarcinoma (aPDAC).
详细描述
This is a national, multicenter, prospective study, including:
- A 14-day (+/-2 days) integrative supportive care program (14-EISCP) initiated as early as the clinical suspicion of aPDAC,
- Follow-up period after the 14-EISCP.
ECOG PS ≥2 patients with pathologically confirmed or suspected aPDAC on imaging were included at first oncology visit in the 14-EISCP including pain, nutritional, diagnostic and stenting procedures.
Post-EISCP ECOG PS ≤1 patients received mFOLFIRINOX or gemcitabine/nab-paclitaxel, ECOG PS ≥2 patients received mFOLFOX7 or investigator choice chemotherapy or best supportive care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Pathologically confirmed or highly suspected aPDAC defined as a pancreatic mass on imaging, suspected distant metastases, no features suggestive of a neuroendocrine tumor, and/or clinico-biological abnormalities compatible with the diagnosis of aPDAC,
- •Age ≥ 18 years,
- •Patients with ECOG PS ≥ 2 and clinico-biological features precluding initial therapeutic clinical trial and/or treatment with FOLFIRINOX or gemcitabine + nab-paclitaxel,
- •No prior history of cancer, except: in situ breast, cervix cancer, or basal cell carcinoma and/or complete remission for more than 3 years from another cancer.
- •Registration in France with the French National Health Care System (CMU included)
- •Patient able to comply with study protocol requirements in the view of the investigator,
- •Before patient registration, written informed consent must be obtained according to ICH/GCP and national/local regulations,
- •Patients requiring at least two components of the integrative care program (pain management, nutritional management, pathological assessment or imaging, and endoscopy/stent).
排除标准
- •Any medical, psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial,
- •Patient protected by law,
- •Pregnant or breast feeding women
研究组 & 干预措施
14-day emergency integrative supportive care program (14-EISCP)
The 14-EISCP starts with the end of visit 1:
- The investigator must determine which procedures have to be undertaken within the following 14 days (+/- 2 days):
- Pain management,
- Nutritional management,
- Pathological examination and site of biopsy,
- Imaging,
- Endoscopy for diagnosis purpose or for biliary/duodenal stenting.
At the end of the visit the investigator must plan all the supportive care and procedures indicated for the patient and indicate those within a specific form
干预措施: 14-EISCP (Other)
结局指标
主要结局
The rate of 14-EISCP success
时间窗: 14 days (+/- 2 days)
The success is determined by: Program Feasibility : The 14-EISCP is considered feasible if the planned procedures, established during the initial consultation with the investigator, is completed within 14 days (+/- 2 days) following the first consultation, or before the start of chemotherapy if it started within 14 days. and Clinical Benefit at 30 days post-consultation defined by one of the following criteria: 1. An improvement of ECOG PS from ≥2 to 1 or 0. 2. A ≥5-point improvement in either fatigue, pain, or global health, as measured by the QLQ-C15-PAL, with no worsening in ECOG PS or the dimensions of fatigue, pain, and global health compared to baseline values. 3. The initiation of chemotherapy within 30 days of consultation. If none of the above criteria (1), (2), or (3) are met, the clinical benefit was considered absent, and the outcome was classified as a failure. The success of the 14-EISCP was defined by success of both criteria.
次要结局
- Delay from the first symptom of aPDAC to the first medical appointment(Up to 2-3 months)
- The rate of patients with improved ECOG PS and/or clinico-biological parameters after 14-EISCP.(14 days; at the end of the 14-EISCP)
- The rate of patients receiving chemotherapy and rate of patients with type of chemotherapy effectively given after the 14-EISCP.(At 14 days, at 21 days, up to death)
- The mean change of health-related quality of life (HRQoL) score(at 30 days)
- Progression-free survival (PFS) assessment(up to 2 years)
- Overall survival (OS) assessment(up to 2 years)
- The change of health-related quality of life (HRQoL)(Month 1 and every two months up to two years)