Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT06040801

Effect of Geriatric Intervention in Frail Patients with Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy

Led by Chang Gung Memorial Hospital · Updated on 2025-02-13

138

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Geriatric Intervention in Frail Patients with Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged sixty-five or older with metastatic or unresectable gastric, biliary, and pancreatic cancer.
  • The patient must sign the informed consent form.
  • Estimated survival period of more than 3 months.
  • Conscious and able to communicate verbally or in writing, and willing to cooperate with invasive procedures.
Not Eligible

You will not qualify if you...

  • Patients with cognitive impairment or unable to cooperate with the interventional procedures as determined by the clinical physician.
  • Patients receiving concurrent other anticancer treatments (radiation or surgery).
  • Patients with multiple types of cancer requiring simultaneous treatment.
  • Patients who have previously participated in this study during a prior chemotherapy regimen.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital

Taoyuan, Taiwan, Taiwan, 330

Actively Recruiting

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Research Team

W

Wen-Chi Chou, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Effect of Geriatric Intervention in Frail Patients with Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy | DecenTrialz