Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).

February 19, 2025 updated by: Shanghai Zhongshan Hospital

A Single-center, Prospective, Observational Cohort Study of 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with locally advanced pancreatic cancer who are evaluated by imaging at Shanghai Zhongshan hospital, aged between 70 and 85 years old, will be screened and enrolled after discussion by the ZSPAC multidisciplinary expert committee.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of first therapy administration to one year later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of first therapy administration to within 90 days, up to 24 months
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
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.
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.
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.
From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSPAC-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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