Search MeSHNCT07144618
Investigating the Correlation Between Pre-Treatment Imaging-Derived Body Composition, Chemotherapy Dose Adjustment, and Treatment Efficacy in Gynecological Cancer Patients "
A study testing National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis Software in people with Search MeSH, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The dosage of paclitaxel, an adjuvant chemotherapy agent for endometrial and ovarian cancer, is typically calculated based on the patient's body surface area (BSA). However, cancer patients with the same BSA may exhibit significant differences in body composition, which could influence the distribution pattern of… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Search MeSH
- What is being tested?
- National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to participate in this clinical trial, with signed informed consent.
- Underwent an abdominal computed tomography (CT) scan within three months prior to surgical treatment, with a non-contrast-enhanced single-slice image at the third lumbar vertebral level available for body composition analysis.
- Histologically or cytologically confirmed diagnosis of endometrial cancer or ovarian cancer.
- Age between 20 and 80 years.
- Good performance status (ECOG performance status of 0, 1, or 2).
- Adequate hematologic parameters:
Show all 25Show fewer
- Hemoglobin ≥10 g/dL
- White blood cell count ≥3,000/μL
- Neutrophil count ≥1,500/μL
- Platelet count ≥100,000/μL
- Adequate organ function:
- Total bilirubin ≤1.5 times the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤2.5 times ULN (≤5.0 times ULN for patients with liver metastases).
- Creatinine ≤ ULN. Exclusion Criteria
- 1. Presence of other major diseases that may be exacerbated by chemotherapy (e.g., autoimmune diseases).
- 2. History of other malignancies within the past two years before trial enrollment, except for adequately treated non-melanoma skin cancer, stage 0 cervical carcinoma, or ductal carcinoma in situ of the breast.
- 3. Requirement for concurrent treatment of unrelated diseases during the trial period, including chemotherapy, radiotherapy, or investigational drugs.
- 4. Mental status deemed unsuitable for participation in the clinical trial. 5. Expected survival time of less than six months. 6. Poor-quality abdominal CT images, clearly attributable to the following causes:
- Motion artifacts due to poor patient compliance.
- Noticeable scoliosis or kyphosis.
- Multiple lumbar vertebral compression fractures.
- Significant generalized edema.
- Presence of metallic implants in the lumbar spine or abdomen.
- Abdominal stoma or significant abdominal wall defects.
- Marked asymmetry or localized atrophy/deficiency of the core abdominal musculature.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Cheng Kung University Hospital
Tainan, 704
Pei-Ying Wu, +886-6-235-3535 Ext:5222, anna1002ster@gmail.com
Keng-Fu Hsu
About this study
Official title: A Multicenter Ambidirectional Study Investigating the Association Between Pre-Treatment Imaging-Derived Body Composition, Chemotherapy Dose Adjustment, and Treatment Efficacy in Patients With Endometrial and Ovarian Cancer
The dosage of paclitaxel, an adjuvant chemotherapy agent for endometrial and ovarian cancer, is typically calculated based on the patient's body surface area (BSA). However, cancer patients with the same BSA may exhibit significant differences in body composition, which could influence the distribution pattern of paclitaxel in the body. These variations may lead to individual differences in drug tolerance and adverse effects. Such variability not only impacts the patient's treatment experience and quality of life but may also increase medical costs, including hospitalization, emergency department visits, and additional treatments required to manage chemotherapy-induced toxicities.
Our preliminary study results indicate that skeletal muscle area (SMA) and skeletal muscle index (SMI), as assessed through computed tomography (CT) imaging, are significantly associated with the incidence of Grade 3 or higher leukopenia or neutropenia following the first two cycles of chemotherapy in patients with endometrial cancer. Furthermore, the predictive accuracy of these CT-derived muscle measurements surpasses the clinical judgment made by physicians based on conventional treatment guidelines. Patients who develop Grade 3 or higher leukopenia or neutropenia during the first two cycles are more likely to experience more frequent occurrences of Grade 3 or higher chemotherapy-related adverse effects in subsequent treatment cycles.
Read more
However, no study has comprehensively investigated the relationship between body composition, chemotherapy dosing, and adverse effects. Therefore, this trial aims to examine the impact of body composition on chemotherapy dose adjustments and adverse effects. By utilizing body composition data extracted from abdominal CT imaging through this product, this study seeks to establish a risk stratification tool to assist physicians in treating patients with endometrial and ovarian cancer by providing a reference for chemotherapy dose reduction.
It is expected that through a precision chemotherapy strategy, the incidence of chemotherapy-related adverse effects can be reduced, thereby lowering medical resource expenditures incurred from managing these adverse effects, such as emergency department visits, hospitalizations, additional diagnostic tests, and supportive medication costs. Furthermore, this approach aims to improve patients' health-related quality of life and achieve a dual benefit of medical economic efficiency and clinical effectiveness.
Read the detailed description
Endometrial cancer ranks sixth in incidence among women worldwide and is rising, while ovarian cancer, though less common, remains the leading cause of gynecologic cancer mortality. Standard adjuvant chemotherapy for these malignancies includes paclitaxel (dose based on body surface area, BSA) and carboplatin (dose based on AUC). However, BSA-based dosing does not account for variations in body composition, which can significantly influence drug distribution, toxicity, and treatment efficacy.
Retrospective analysis of 124 endometrial cancer patients at National Cheng Kung University Hospital demonstrated that CT-derived skeletal muscle parameters (SMA, SMI) are significantly associated with grade ≥3 hematologic toxicities and outperform traditional clinical judgment for risk prediction. Patients experiencing severe hematologic toxicity within the first two cycles are more likely to experience repeated toxicities in subsequent cycles.
This trial integrates prospective randomized controlled trial (RCT) and retrospective target trial emulation.
Prospective RCT: 294 patients will be stratified by cancer stage and randomized 1:1 to intervention vs. control groups. The intervention group will undergo AI-assisted risk stratification based on preoperative CT body composition analysis, with high-risk patients receiving a 15% paclitaxel dose reduction from cycle 1. The control group will receive standard-of-care dosing adjustments based on clinical judgment.
Retrospective analysis: Patients diagnosed from 2012-2024 with available CT images and complete treatment records will be analyzed using propensity score methods to control for confounders.
Primary endpoint: incidence of grade ≥3 leukopenia or neutropenia within the first two cycles.
Secondary endpoints: chemotherapy cycle delay (>7 days), hospitalization rate, HRQoL (CIPN, EORTC-QoL), two-year PFS and OS, cost-effectiveness (ICER, VBP).
The trial hypothesizes that AI-guided dosing adjustments will reduce severe hematologic toxicity rates from 75% to 60% without compromising relative dose intensity (>85%), thereby achieving both clinical and economic benefits.
- Conditions
- Search MeSH
- Being tested
- National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis Software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis SoftwareDevice
Phase 2: The second phase will involve a prospective multicenter clinical trial, enrolling 294 patients with endometrial or ovarian cancer.Patients will be randomized into two groups (at least 147 per group): AI-assisted group (treatment group): Preoperative CT imaging will be used to assess body composition and classify patients into high-risk or low-risk categories.Chemotherapy dosing will be adjusted accordingly to evaluate treatment-related adverse effects and dose modifications. Non-AI-assisted group (control group): Patients will receive chemotherapy chemotherapy dosing adjustments based on standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Phase 2: Prospective Multicenter Clinical Trial
The second phase will involve a prospective multicenter clinical trial, enrolling 294 patients with endometrial or ovarian cancer.Patients will be randomized into two groups (at least 147 per group):
1. AI-assisted group (treatment group): Preoperative CT imaging will be used to assess body composition and classify patients into high-risk or low-risk categories.Chemotherapy dosing will be adjusted accordingly to evaluate treatment-related adverse effects and dose modifications.
2. Non-AI-assisted group (control group): Patients will receive chemotherapy dosing adjustments based on standard clinical care practices. Receives: Device: National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis Software |
| Control | No intervention | Control Group (Standard chemotherapy dose adjustment without AI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of predicting the risk of Grade 3 or higher leukopenia or neutropenia as an adverse effect in endometrial and ovarian cancer patients undergoing postoperative adjuvant chemotherapy (including Paclitaxel) during the first two treatment cycles
Statistical methods:
- The primary endpoint is a categorical variable, representing the incidence rate of patients experiencing adverse effects. Chi-square test or Fisher's exact test will be used to compare the incidence of Grade 3 or higher chemotherapy-related adverse effects between the experimental group (AI-assisted dose adjustment) and the control group (dose adjustment based on standard clinical guidelines).
- Considering the impact of adverse effects across treatment cycles, a Generalized Estimating Equation (GEE) analysis will be performed to assess the overall differences between groups.
Analysis approach: An intent-to-treat (ITT) analysis will be conducted, including all randomized participants to minimize selection bias.
Measured: 6 weeks
Secondary outcomes (1)
Secondary endpoints include: Chemotherapy cycle delay, admission rate, health-related quality of life, two-year survival rates (PFS, OS), and cost-effectiveness.
Chemotherapy Cycle Delay Description: % of patients with >7-day delay in any chemo cycle (21 days/cycle). Time Frame: First two cycles Unit: % of participants Hospitalization Rate Description: % of patients hospitalized at least once during chemo. Time Frame: Up to 2 years Unit: % of participants HRQoL - CIPN Score Description: Change in CIPN score from baseline. Time Frame: Baseline, during chemo, 1-year follow-up Unit: Scale units (CIPN) HRQoL - EORTC-QoL Score Description: Change in EORTC-QoL global health status score. Time Frame: Baseline, during chemo, 1-year follow-up Unit: Scale units (EORTC-QoL) Progression-Free Survival (PFS) Description: Time from first chemo to progression or death. Time Frame: Up to 24 months Unit: Months Overall Survival (OS) Description: Time from first chemo to death from any cause. Time Frame: Up to 24 months Unit: Months Incremental Cost-Effectiveness Ratio (ICER) Description: Cost/QALY for AI-assisted vs. standard dosing. Time Frame: Up to 2 year
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startSep 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Search MeSHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144618
- Sponsor's protocol ID
- A-BR-114-031-T
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Ambidirectional Study Investigating the Association Between Pre-Treatment Imaging-Derived Body Composition, Chemotherapy Dose Adjustment, and Treatment Efficacy in Patients With Endometrial and Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07144618
- Acronym / sponsor ID
- A-BR-114-031-T
- Conditions
- Search MeSH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The dosage of paclitaxel, an adjuvant chemotherapy agent for endometrial and ovarian cancer, is typically calculated based on the patient's body surface area (BSA). However, cancer patients with the same BSA may exhibit significant differences in body composition, which could influence the distribution pattern of paclitaxel in the body. These variations may lead to individual differences in drug tolerance and adverse effects. Such variability not only impacts the patient's treatment experience and quality of life but may also increase medical costs, including hospitalization, emergency department visits, and additional treatments required to manage chemotherapy-induced toxicities.
Our preliminary study results indicate that skeletal muscle area (SMA) and skeletal muscle index (SMI), as assessed through computed tomography (CT) imaging, are significantly associated with the incidence of Grade 3 or higher leukopenia or neutropenia following the first two cycles of chemotherapy in patients with endometrial cancer. Furthermore, the predictive accuracy of these CT-derived muscle measurements surpasses the clinical judgment made by physicians based on conventional treatment guidelines. Patients who develop Grade 3 or higher leukopenia or neutropenia during the first two cycles are more likely to experience more frequent occurrences of Grade 3 or higher chemotherapy-related adverse effects in subsequent treatment cycles.
However, no study has comprehensively investigated the relationship between body composition, chemotherapy dosing, and adverse effects. Therefore, this trial aims to examine the impact of body composition on chemotherapy dose adjustments and adverse effects. By utilizing body composition data extracted from abdominal CT imaging through this product, this study seeks to establish a risk stratification tool to assist physicians in treating patients with endometrial and ovarian cancer by providing a reference for chemotherapy dose reduction.
It is expected that through a precision chemotherapy strategy, the incidence of chemotherapy-related adverse effects can be reduced, thereby lowering medical resource expenditures incurred from managing these adverse effects, such as emergency department visits, hospitalizations, additional diagnostic tests, and supportive medication costs. Furthermore, this approach aims to improve patients' health-related quality of life and achieve a dual benefit of medical economic efficiency and clinical effectiveness.
Detailed description
Endometrial cancer ranks sixth in incidence among women worldwide and is rising, while ovarian cancer, though less common, remains the leading cause of gynecologic cancer mortality. Standard adjuvant chemotherapy for these malignancies includes paclitaxel (dose based on body surface area, BSA) and carboplatin (dose based on AUC). However, BSA-based dosing does not account for variations in body composition, which can significantly influence drug distribution, toxicity, and treatment efficacy.
Retrospective analysis of 124 endometrial cancer patients at National Cheng Kung University Hospital demonstrated that CT-derived skeletal muscle parameters (SMA, SMI) are significantly associated with grade ≥3 hematologic toxicities and outperform traditional clinical judgment for risk prediction. Patients experiencing severe hematologic toxicity within the first two cycles are more likely to experience repeated toxicities in subsequent cycles.
This trial integrates prospective randomized controlled trial (RCT) and retrospective target trial emulation.
Prospective RCT: 294 patients will be stratified by cancer stage and randomized 1:1 to intervention vs. control groups. The intervention group will undergo AI-assisted risk stratification based on preoperative CT body composition analysis, with high-risk patients receiving a 15% paclitaxel dose reduction from cycle 1. The control group will receive standard-of-care dosing adjustments based on clinical judgment.
Retrospective analysis: Patients diagnosed from 2012-2024 with available CT images and complete treatment records will be analyzed using propensity score methods to control for confounders.
Primary endpoint: incidence of grade ≥3 leukopenia or neutropenia within the first two cycles.
Secondary endpoints: chemotherapy cycle delay (>7 days), hospitalization rate, HRQoL (CIPN, EORTC-QoL), two-year PFS and OS, cost-effectiveness (ICER, VBP).
The trial hypothesizes that AI-guided dosing adjustments will reduce severe hematologic toxicity rates from 75% to 60% without compromising relative dose intensity (>85%), thereby achieving both clinical and economic benefits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis SoftwarePhase 2: Prospective Multicenter Clinical Trial The second phase will involve a prospective multicenter clinical trial, enrolling 294 patients with endometrial or ovarian cancer.Patients will be randomized into two groups (at least 147 per group): 1. AI-assisted group (treatment group): Preoperative CT imaging will be used to assess body composition and classify patients into high-risk or low-risk categories.Chemotherapy dosing will be adjusted accordingly to evaluate treatment-related adverse effects and dose modifications. 2. Non-AI-assisted group (control group): Patients will receive chemotherapy dosing adjustments based on standard clinical care practices. |
| Control | No intervention | –Control Group (Standard chemotherapy dose adjustment without AI) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Able to comprehend and willing to participate in this clinical trial, with signed informed consent.
- Underwent an abdominal computed tomography (CT) scan within three months prior to surgical treatment, with a non-contrast-enhanced single-slice image at the third lumbar vertebral level available for body composition analysis.
- Histologically or cytologically confirmed diagnosis of endometrial cancer or ovarian cancer.
- Age between 20 and 80 years.
- Good performance status (ECOG performance status of 0, 1, or 2).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis SoftwarePhase 2: The second phase will involve a prospective multicenter clinical trial, enrolling 294 patients with endometrial or ovarian cancer.Patients will be randomized into two groups (at least 147 per group): AI-assisted group (treatment group): Preoperative CT imaging will be used to assess body composition and classify patients into high-risk or low-risk categories.Chemotherapy dosing will be adjusted accordingly to evaluate treatment-related adverse effects and dose modifications. Non-AI-assisted group (control group): Patients will receive chemotherapy chemotherapy dosing adjustments based on standard clinical care. | Device | Experimental Group |
Primary outcome
The accuracy of predicting the risk of Grade 3 or higher leukopenia or neutropenia as an adverse effect in endometrial and ovarian cancer patients undergoing postoperative adjuvant chemotherapy (including Paclitaxel) during the first two treatment cycles
Time frame: 6 weeks
Statistical methods: 1. The primary endpoint is a categorical variable, representing the incidence rate of patients experiencing adverse effects. Chi-square test or Fisher's exact test will be used to compare the incidence of Grade 3 or higher chemotherapy-related adverse effects between the experimental group (AI-assisted dose adjustment) and the control group (dose adjustment based on standard clinical guidelines). 2. Considering the impact of adverse effects across treatment cycles, a Generalized Estimating Equation (GEE) analysis will be performed to assess the overall differences between groups. Analysis approach: An intent-to-treat (ITT) analysis will be conducted, including all randomized participants to minimize selection bias.
1 secondary outcome
Secondary endpoints include: Chemotherapy cycle delay, admission rate, health-related quality of life, two-year survival rates (PFS, OS), and cost-effectiveness.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing National Cheng Kung University Abdominal Muscle Group Medical Imaging Analysis Software in people with Search MeSH, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-Ying Wu (+886-6-235-3535 Ext:5222, anna1002ster@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of predicting the risk of Grade 3 or higher leukopenia or neutropenia as an adverse effect in endometrial and ovarian cancer patients undergoing postoperative adjuvant chemotherapy (including Paclitaxel) during the first two treatment cycles (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.