Status:
NOT_YET_RECRUITING
Investigating the Correlation Between Pre-Treatment Imaging-Derived Body Composition, Chemotherapy Dose Adjustment, and Treatment Efficacy in Gynecological Cancer Patients "
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Search MeSH
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief 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 s...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT07144618
Start Date
September 1 2025
End Date
December 31 2028
Last Update
September 22 2025
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan, 704