Zhongshan Hospital
Shanghai, China
Not Yet Recruiting
NCT Number: NCT06844773
Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
The goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. The main question it aims to answer is:
Does chemoradiotherapy represent an effective and safe treatment for older participants without radical surgery? Participants will sequentially receive combined chemotherapy followed by concurrent chemoradiotherapy and subsequent maintenance therapy.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
70 year–85 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Voluntarily participate and sign the informed consent form
- Age 70-85 years old, life expectancy > 1 year and gender is not limited
- Eastern Cooperative Oncology Group Physical Status Score (ECOG) physical state score<=1 point
- Pathological or cytological confirmation of pancreatic ductal adenocarcinoma (including IPMN malignant transformation, acinar carcinoma, etc., excluding adenosquamous cell carcinoma and neuroendocrine carcinoma)
- The clinical stage is stage III (locally advanced pancreatic cancer), and no radical surgery has been performed (bypass surgery is acceptable), or the patient has resectable pancreatic cancer, but cannot accept surgery or refuse surgery due to physical strength or concomitant diseases
- Have not received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
- No serious hematological, cardiological, pulmonary function abnormalities and autoimmune deficiencies (refer to their respective diagnostic criteria)
- Blood routine index: white blood cell (WBC) >=3.0 × 109/L; Absolute neutrophil count (ANC) >=1.5 × 109/L; Platelets (PLT) >=100 × 109/L; hemoglobin (Hgb) >=90 g/L
- Blood biochemical indexes: AST (SGOT), ALT (SGPT) <=2.5 × upper limit of normal value (ULN); Total bilirubin (TBIL) < = ULN; Serum creatinine (CRE) <=1.5 × ULN
- Coagulation function: prothrombin time (PT), international normalized ratio (INR) <=1.5 × ULN
- Able to comply with the requirements of the study visit plan and other programs.
Exclusion criteria
- Accompanied by malignant tumors of other systems
- Received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
- Have used any other non-anti-tumor research drugs within 4 weeks before treatment
- Combined with uncontrollable hypertension, diabetes, infection, etc.
- Poor compliance, unable or unwilling to sign informed consent
- Patients who are expected to be out of the observation period for 14 days or more during the treatment period.
Treatment and study plan
Primary outcomes
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1-year survival rate
Time frame: From the date of first therapy administration to one year later
To observe whether the 1-year survival rate of elderly patients with locally advanced pancreatic cancer treated with sandwich-like chemoradiotherapy modality was comparable to that of the historical data of the general adult population.
Secondary outcomes
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Toxicity and side effects and tolerability assessment
Time frame: From the date of first therapy administration to within 90 days, up to 24 months
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTCAE Version 5.0.
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event-free survival throughout the enrolled subject population
Time frame: From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Survival time from the start of therapy administration to the date of first documented progression or the date of death
-
the proportion of participants that completed chemoradiotherapy
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
-
the proportion ofparticipants that completed all planned courses
Time frame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
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Objective response rate (ORR) tumor target lesions in the entire subject population all planned courses
Time frame: From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
ORR is defined as the percentage of patients who achieve complete response (CR) or partial response (PR) based on the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
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Disease control rate (DCR) of tumor target lesions in the entire subject population all planned courses
Time frame: From date of first therapy administration until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 24 months.
DCR is defined as the percentage of patients who achieved CR, PR and stable disease (SD), and will be evaluated based on RECIST 1.1 and the irRECIST criteria.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shanghai Zhongshan Hospital
Other
Registry information
Official study title
A Single-center, Prospective, Observational Cohort Study of Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Feb 25, 2025
- Registry last updated
- Feb 25, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.