A Prospective Study of Concurrent Hyperthermia Plus Standard of Care in Borderline and Locally Advanced Pancreatic Cancer (PANHEAT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
The project proposes a prospective multicenter study to evaluate the incorporation of deep regional hyperthermia into the standard of care neoadjuvant chemotherapy (mFOLFIRINOX/NABPACLITAXEL) followed by radiotherapy in borderline and locally advanced ductal adenocarcinoma pancreatic cancer. Although current treatments, based on induction chemotherapy followed by surgery or radiotherapy in selected patients, have improved survival and resection rates, overall survival remains poor.
Hyperthermia is a therapeutic intensification strategy with a solid biological basis. By controlling tumor heating (39-43°C), it enhances the efficacy of chemotherapy and radiation therapy by improving tumor oxygenation, increasing perfusion, and inhibiting DNA damage repair, without adding significant systemic toxicity. The available clinical evidence, although based mainly on retrospective and small studies, suggests that the combination of HRP with multimodal treatments improves local control, favors conversion to surgery, and may prolong survival while maintaining a favorable safety profile.
The protocol contemplates the initial administration of induction chemotherapy (preferably mFOLFIRINOX or, alternatively, gemcitabine with nab-paclitaxel)plus hyperthermia followed by multidisciplinary reevaluation. Patients who deemed resectable will undergo surgery and adjuvant chemoradiotherapy and hyperthermia. Patients without metastatic progression who remain unresectable will receive SBRT in five fractions along with sessions of deep regional hyperthermia. Subsequently, the possibility of surgery will be assessed again and a standardized follow-up will be carried out with clinical, radiological, biochemical and pathological evaluation when appropriate.
The main objective of the study is to determine the impact of this strategy on overall survival. Secondary objectives will be to evaluate progression-free survival, local control, conversion rate to surgery, proportion of R0 resections, tumor response, safety, tolerability, and feasibility of treatment. With this, the study aims to provide prospective evidence on the role of hyperthermia as a therapeutic intensification strategy in localized pancreatic cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of borderline or Locally advanced pancreatic cancer
- •Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy/cytology).
- •ECOG performance scale 0 and
- •Age between 18 and 80 years.
- •Adequate kidney functionality defined as creatinine clearance >50 ml/min.
- •Adequate liver functionality defined as total bilirubin ≤2 times of the upper limit of normal.
- •Adequate bone marrow reserves: WBC count ≥2.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin ≥8.0 g/L.
- •Women of child-bearing age must secure sufficient contraception control (dual protection with condoms and pills) during the clinical trial and 6 months after the clinical trial is completed.
- •For females of child bearing potential, pregnancy test within 2 week prior to randomization should be negative.
- •Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule.
排除标准
- •Absence of distant metastasis or gross peritoneal carcinomatosis.
- •Prior or concurrent malignancies.
- •Patients having metal implants, pacemakers or clustered markers.
- •Patients with metallic endobiliary stent would need to be replaced with plastic stents.
- •Any history of myocardial infarction within the past 12 months.
- •Any connective tissue disorder that contraindicate RT, e.g., scleroderma.
- •Pre-existing grade 2 peripheral neuropathy.
- •Any known contraindication or hypersensitivity to the chemotherapeutic agents used in the study as decided by the medical oncologists.
- •Pregnancy, lactation period or lack of reliable contraception.
- •Any other disease or therapy, which, according to the investigator, present a risk to the patient or which are not compatible with the aims of the clinical trial.
- •Indications that the person concerned will possibly not keep to the clinical trial plan because of unwillingness to cooperate or difficulties in keeping the check-up appointments.
研究组 & 干预措施
Hyperthermia plus neoadjuvant chemotherapy/radiotherapy
Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyperthermia plus adjuvant chenmotherapy+/-radiotherapy b) surgically non-resectable: hyperthermia plus SBRT
干预措施: Hyperthermia plus neoadjuvant chemotherapy/radiotherapy Arm Description: Hyperthermia plus neoadjuvant chemotherapy (mFOLFIRINOX/nab Paclitaxel) followed by a) surgically resectable: Hyp (Device)
结局指标
主要结局
overall survival
时间窗: one year
Time from included in the study to death for any cause
次要结局
- Progression Free Survival(one year)
- Objective response rate (ORR)(6 months)
- disease control rate (DCR),(6 months)
- Biochemical response using CEA and CA 19-9.(6 months)
- Conversion rate to surgery.(6 months)
- R0 resection rate(7 months)
- Pathological response, including ypTNM and GRT.(7 months)
- Local progression-free survival as first cause of failure(one year)
- Acute and late toxicity chemotherapy and radiotherapy(Acute: one month. Late: 12 months)
研究者
Pedro C Lara
Professor of Oncology
Fernando Pessoa Canarias University