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NCT Number: NCT07837505

Integrating Geriatric 8 (G8) Screening and Cancer and Age Research Group (CARG) Toxicity Assessment Score Into Routine Care for Older Adults With Cancer

This study evaluates whether using specialized geriatric screening and toxicity prediction tools can help oncologists personalize chemotherapy dosing and reduce severe side effects in older adults with solid cancers.

Older adults with cancer have diverse levels of physical resilience and functional reserve that standard oncologic performance scores often miss. Consequently, uniform standard chemotherapy dosing can lead to severe, life-threatening toxicities, unplanned hospitalizations, or early treatment discontinuation.

In this prospective-retrospective comparative study, patients aged 65 years and older who are starting chemotherapy are prospectively evaluated using the Geriatric 8 (G8) screening tool. Patients identified as vulnerable (G8 score ≤ 14) undergo a Comprehensive Geriatric Assessment (CGA) across functional, nutritional, cognitive, and psychological domains. In addition, all prospective participants are evaluated using the Cancer and Age Research Group (CARG) toxicity tool to calculate their risk of severe side effects. Chemotherapy doses are risk-adapted based on CARG scores:

* Low Risk: Standard chemotherapy dose * Intermediate Risk: 20% dose reduction * High Risk: 50% dose reduction

Participants are followed every 3 months for 1 year to evaluate treatment tolerance, adherence, tumor response, and survival. These outcomes will be compared against a historical retrospective cohort of older patients with solid tumors who received standard-dose chemotherapy without G8 screening or CARG toxicity risk stratification.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

Inclusion criteria

  • Age 65 years or older
  • Confirmed diagnosis of any solid malignancy
  • Scheduled to initiate cytotoxic chemotherapy

Exclusion criteria

  • Hematological malignancies (e.g., leukemia, lymphoma)
  • Treatment plans consisting exclusively of non-chemotherapy modalities (e.g., endocrine therapy, immunotherapy monotherapy, or radiotherapy alone)
  • Incomplete or missing medical records (applicable to the retrospective historical control cohort)

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Grade 3 to 5 Chemotherapy-Related Toxicities

    Time frame: Up to 12 months

    Percentage of participants who experience at least one severe, life-threatening, or fatal (Grade 3, 4, or 5) adverse event related to chemotherapy. Toxicities are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) criteria.

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Integrating Geriatric 8 (G8) Screening and Cancer and Age Research Group (CARG) Toxicity Assessment Score Into Routine Oncology Care for Older Adults With Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

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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