Pilot Study of Geriatric Parameters and Quality of Life in Patients Over 70 Years Old Undergoing Pancreatic Cancer Surgery
Pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. In France, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men. Surgery is currently the only curative option available to patients, but it is not an option for many patients who already have metastatic or locally advanced cancer at the time of diagnosis. The main studies carried out on this type of intervention in the elderly focus on the surgical aspect, and the tolerability of such surgery is not well studied. The aim of this study is to describe the impact of pancreatic surgery on the independence in daily activities and quality of life of patients aged over 70 with pancreatic cancer. These patients underwent surgery at Édouard Herriot Hospital (Hospices Civils de Lyon) since July 2021, and the assessment will be conducted through telephone questionnaires. It is hypothesised that these patients will be able to maintain their independence in terms of daily activities.
NCT06079229 — Pancreatic Cancer
Status: Completed
http://inclinicaltrials.com/pancreatic-cancer/NCT06079229/
A Phase II Multicentric Study of Olaparib in PALB2-related Advanced Pancreatic Cancer (PALBOLA)
This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.
NCT06078787 — Metastatic Pancreatic Cancer
Status: Recruiting
http://inclinicaltrials.com/metastatic-pancreatic-cancer/NCT06078787/
Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes. The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery. In addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored. Included patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.
NCT06069297 — Pancreatic Cancer
Status: Recruiting
http://inclinicaltrials.com/pancreatic-cancer/NCT06069297/
Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study
Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned. The aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes. Primary outcome 1) To determine incidence of PALN metastasis in patients submitted to a tentative curative resection Secondary outcomes 1. To determine prognosis of patients with PALN metastasis after a curative resection 2. To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection. 3. To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection. 4. To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report. 300 patients are planned to be included in the trial.
NCT06065891 — Pancreas Cancer
Status: Recruiting
http://inclinicaltrials.com/pancreas-cancer/NCT06065891/
Improving Pancreatic Cancer Care by the Use of Computational Science and Technology
The goal of the IMPACT project is to set up a data sharing infrastructure between expert centers for pancreatic surgery that enables training, testing and validation of computer science tools to improve quality of care for patients with pancreatic cancer.
NCT06055010 — Pancreatic Cancer
Status: Recruiting
http://inclinicaltrials.com/pancreatic-cancer/NCT06055010/
To Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of T Cell Receptor T Cell Therapy in the Treatment of Advanced Pancreatic Cancer
To investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cells in the treatment of advanced pancreatic cancer
NCT06054984 — Pancreatic Cancer
Status: Recruiting
http://inclinicaltrials.com/pancreatic-cancer/NCT06054984/
Sintilimab Plus Chemotherapy and Radiotherapy for Patients With Inoperable Pancreatic Cancer: a Single-arm, Exploratory, Phase II Trial
Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.
NCT06050317 — Pancreas Cancer
Status: Recruiting
http://inclinicaltrials.com/pancreas-cancer/NCT06050317/
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
This is a multicenter, prospective, observational study to evaluate the utility of the Invitae Personalized Cancer MonitoringTM assay for patients with resectable and unresectable pancreatic cancer. Using tumor tissue, a personalized blood test (the Invitae Personalized Cancer MonitoringTM test) will be developed that can be used for repeated monitoring to assess for the presence or absence of circulating tumor DNA (ctDNA). The presence of residual cancer cells after treatment is known as molecular residual disease (MRD) and the detection of ctDNA can provide evidence of the presence of MRD. Participants in this study will have their blood drawn at various time points throughout their cancer treatment to test for ctDNA and monitoring with the Invitae Personalized Cancer MonitoringTM test will continue until disease progression or the duration of the study.
NCT06043921 — Pancreatic Cancer
Status: Recruiting
http://inclinicaltrials.com/pancreatic-cancer/NCT06043921/
Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.
This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study aims to establish a diagnostic prediction model by using elastase 1, common clinical serological examinations, and imaging examinations including endoscopic ultrasonography (EUS), and to explore the diagnostic ability of the model in the high-risk population of PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum and pancreatic tissues to further improve the diagnostic performance of this model. In conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC, especially early resectable PDAC.
NCT06041009 — Pancreatic Neoplasms
Status: Recruiting
http://inclinicaltrials.com/pancreatic-neoplasms/NCT06041009/
Effect of Geriatric Intervention in Frail Patients With Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy
Gastric, biliary and pancreatic cancer are commonly malignancies from gastro- intestinal tract in Taiwan. Because lack of specific symptoms at presentation and effective screening methodology, majority of these patients are diagnosed with metastatic or unresectable disease. Palliative chemotherapy is the good standard of therapy for patients with unresectable gastric, biliary and pancreatic cancer with benefit of prolong survival time and improve quality of life. Although the benefit of palliative chemotherapy seems to be the same for elderly and young cancer patients in clinical study, elderly patients are less frequently treated with chemotherapy or treated with suboptimal dosage. Elderly patients do not receive palliative chemotherapy because concerns of elder age, comorbidity, poor performance, lack of social/economic support and worry about treatment toxicities. The increase in life expectancy of the general population resulted in an increase in the number of elderly patients with cancers referred for palliative chemotherapy. Overtreatment may result in high mortality due to disregard of the aging patients' frailty; on the other hand, under-treatment resulting from over-concern regarding their ability to tolerate treatment, may compromise the survival outcome. Therefore, the appropriately selection of geriatric cancer patients for palliative chemotherapy has to be addressed urgently. Frailty is a progressive decline of physiological reserve leading to multiple functional disability and increases vulnerability to subsequent morbidity and mortality. Frailty is associated with treatment toxicity, chemotherapy tolerance, and survival outcome in clinical oncology. Recent randomized study reported geriatric intervention significantly improved chemotherapy tolerance in elderly patients. Therefore, the American Cancer Association has recommended routine geriatric assessment and intervention in oncogeriatric patients upon providing antitumor treatments. However, the effect of geriatric intervention on chemotherapy tolerance is seldom in Taiwan. This study is an open, randomized, prospective trial to evaluate the effect of geriatric intervention on chemotherapy tolerance in patients with unresectable gastric, biliary, and pancreatic cancer. All patients with receive frailty assessment within 7 days before initiation of first cycle palliative chemotherapy followed by geriatric intervention. The study aim is to compare for chemotherapy tolerance, treatment-related toxicity, and quality of life after completion 3 months chemotherapy treatment course between frail and non-frail patients. This study also aims to explore the effect of geriatric intervention of treatment tolerance, treatment-related toxicity, and quality of life in frail patients with gastric, biliary, and pancreatic cancer receiving palliative chemotherapy.
NCT06040801 — GI Cancer
Status: Recruiting
http://inclinicaltrials.com/gi-cancer/NCT06040801/