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| Name | Class |
|---|---|
| Misr International University | OTHER |
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The aim of the current study is to compare weekly versus three-week collective of carboplatin/paclitaxel in advanced epithelial ovarian cancer. The author's hypothesis was to study and correlate routine laboratory tests, clinical biomarkers and quality of life questionnaires between weekly and three-week standard carboplatin regimens in order to reveal any possible superiority for the weekly study arm.
Ovarian cancer as the fifth leading cause of death in women worldwide. Since most women suffer asymptomatic manifestations or nonspecific symptoms, subsequent diagnosis is very tricky and late most of the time. Carboplatin/paclitaxel has been among the first line options for treatment of ovarian cancer for decades however, account for a great of deal of adverse effects affecting patient safety. These side effects are dose related whereas, dose of carboplatin is calculated individually for each patient using the Calvert equation focusing on renal functions at baseline. Carboplatin adverse effects are believed to mainly affect the kidneys, hematological system and may cause neurotoxicity thus, exhibit quality of life deteriorations.
The study purpose was to investigate a triple correlation between 3 different aspects comparing the weekly dose versus the three-week dense dose of carboplatin/paclitaxel in treating advanced epithelial ovarian cancer.
Points of comparison:
The study encouraged the patient right to be involved and consent to the assigned protocol
The correlation between all three aspects studied as of routine lab work, toxicity biomarkers and quality of life besides the economic burden aim to provide a decent patient tailored treatment regimen balancing efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly dose of carboplatin / paclitaxel (n=21) | Experimental | Patients in this group received the weekly dose regimen, where the dose of carboplatin administered intravenously once/week was calculated using the Calvert equation to yield an area under the curve (AUC) = 2 |
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| 3-Week collective dense dose of carboplatin / paclitaxel (n=28) | Active Comparator | Patients in this group received the three-week collective dose regimen, where the dose of carboplatin was administered intravenously once on day 1/ every three weeks (21 days) and was calculated using the Calvert equation to yield an AUC = 6 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin/paclitaxel | Drug | Weekly dose versus every three weeks dense dose of carboplatin/paclitaxel regimen in advanced epithelial ovarian cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Routine blood work and tumor markers | Quantitative continuous parameter assay of blood samples to measure hemoglobin gram/deciliter, total leukocyte count, platelets, neutrophils all in (number/unit liter), serum creatinine, blood urea nitrogen, uric acid, serum calcium in (milligram/deciliter), alanine aminotransferase, aspartate aminotransferase in (unit liter), albumin (gram liter), carcinoembryonic antigen (nano-gram milliliter), and cancer antigen-125 (unit milliliter) This was cross-referenced against the universal laboratory values to identify the degree of anemia, neutropenia, thrombocytopenia, calcium deficiency, kidney injury, liver toxicity, and tumor progression comparing pre-and post-treatment results for patients on each regimen separately and also compare post-treatment between the two regimens by end of treatment (weekly dose of carboplatin group and 3-week collective dense dose carboplatin regimens). | 6 cycles for each patient with a total of126 days |
| Additional kidney and anemia biomarkers | Cystatin-C ng/mL, Neutrophil gelatinase-associated lipocalin ng/mL, Interleukin-18 pg/mL, Kidney injury marker-1 ng/mL, and Hepcidin pg/mL Acute kidney injury to the glomerular capsule and proximal tubule was assessed by the increase in Cys-C, NGAL, KIM-1, and IL-18 Anemia and diminished renal clearance resembling kidney injury were measured by increased levels of HEPC Pre-and post-treatment concentrations were compared for patients on each carboplatin regimen & post-treatment concentration by the end of treatment between weekly and collective 3-week dense dose
(Higher marker levels outline greater toxicity) | 6 cycles for each patient with a total of126 days |
| Improved quality of life | Functional assessment of cancer therapy-ovarian (FACT-O) & functional assessment of cancer therapy/Gynecologic Oncology Group neurotoxicity (FACT-GOG-NTX) A 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). FACIT organization developed questions into 5 compartments: {Personal (PWB), Emotional (EWB), Social (SWB), Functional (FWB), Ovarian cancer (OC) & Neurotoxicity (NTX)) Hard copies, consume 10-15 mins to fill, patients documented their responses, guideline reverse calculation & trial outcome indices analyzed Compared at baseline, post-treatment by the end of therapy for each group individually & post-treatment between both carboplatin regimens FACT-G total score = PWB + EWB + SWB + FWB FACT-O total score = PWB + EWB + SWB + FWB + OC FACT/GOG-Ntx total score = PWB + EWB + SWB + FWB + NTX FACT-O Trial Outcome Index (TOI) = PWB + FWB + OC FACT/GOG-Ntx Trial Outcome Index (TOI) = PWB + FWB + NTX High scores = enhanced QOL, low scores = poor QOL |
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Inclusion Criteria:
Stage II: Tumor extends beyond the uterus within the pelvis (invasion of surrounding organs) subdivided into IIA: adnexal involvement, IIB: involvement of other pelvic tissue.
Stage III: Tumor invades abdominal tissue (spread to nodes or tissue within the pelvis), subdivided into: IIIA: one site; IIIB: more than one site; IIIC: metastasis to the pelvic and/or para-aortic lymph node.
Stage IV: Tumor invades external organs to the uterus subdivided into IVA: tumor invading the bladder and/or rectum while IVB: distant metastasis(es).
-Indication for chemotherapy and life expectancy of at least 3 months Performance status is above and equal to 3 according to the Eastern Cooperative Oncology Group (ECOG).
Exclusion Criteria:
Discontinuation criteria:
Epithelial ovarian cancer patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacology and toxicology department, Faculty of Pharmacy, Cairo University. | Cairo | 12613 | Egypt |
Study findings, Experimental module, Ethical approval, Patient consent, Inclusion criterion, Exclusion criteria, Baseline characteristics.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D009503 | Neutropenia |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
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| ID | Term |
|---|---|
| C053518 | CP protocol |
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prospective open-label non-randomized control study
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| 6 cycles for each patient with a total of126 days |
| D000095542 |
| Cytopenia |
| D007960 | Leukocyte Disorders |
| D001791 | Blood Platelet Disorders |