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NCT Number: NCT06040801

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 330

Location status: Recruiting

Location contact

Wen-Chi Chou

CONTACT

[email protected]

+8863281200 ext. 8426

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Frailty intervention measures

Behavioral

Providing management and recommendations based on the specific impairment domain.

Assessment domain:

  • Functional status
  • Nutrition
  • Comorbidity
  • Mobility/Falls
  • Mood
  • Cognition
  • Polypharmacy
  • Social support.

Primary outcomes

  1. Examine the completion rate of chemotherapy in frail and non-frail patient groups three months after treatment initiation to assess whether frailty affects tolerance.

    Time frame: After completion 3 months chemotherapy treatment.

  2. Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-frail patient groups, and compare the differences between the two.

    Time frame: After completion 3 months chemotherapy treatment.

  3. Assess the level of quality of life in frail and non-frail patient groups before and after treatment using EORTC QLQ-C30 v3 and EORTC QLQ-ELD14.

    Time frame: After completion 3 months chemotherapy treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Wen-Chi Chou, M.D.

CONTACT

[email protected]

+886328-1200 ext. 8426

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2023
Registry last updated
Feb 13, 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.

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