Effect of Albumin-bound Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Patients Receiving Neoadjuvant Chemotherapy for Advanced Ovarian, Fallopian Tube or Peritoneal Cancer: A Phase 2 Single Center Clinical Trial

Study Overview
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Brief Summary
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Neoadjuvant chemotherapy (NACT) is an important option for patients with advanced ovarian cancer. Paclitaxel plus carboplatin is the first-line regimen for ovarian cancer NACT patients. However, the efficacy of NACT is controversial, how to improve the efficacy become an urgent problem to be solved in the treatment of ovarian cancer. It has been confirmed that the dose-intensive paclitaxel combined carboplatin regimen can improve the prognosis in Asian patients with advanced ovarian cancer. However, this protocol has a low rate of complete tumor remission after NACT (4%) with toxicities and high probability of severe hypersensitivity reactions. Albumin-bound paclitaxel has the characteristics of tumor targeting, low allergenicity. We propose that dose-dense albumin-bound paclitaxel (ddnab-paclitaxel) (100 mg/m2, days 1, 8, and 15) combined with carboplatin (AUC = 5 days 1, 4 weeks) regimen may be superior to the paclitaxel plus carboplatin regimen. We conducted this Phase II randomized controlled study to testify the efficacy of dd-nab paclitaxel. 57 stage IIIC-IV patients with high-grade epithelial, fallopian tube, and peritoneal cancer who are unable to undergo optimal cytoreduction and receive NACT after tumor biopsy will be recruited. The regimen for the study group is albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15 doses) combined with carboplatin (AUC = 5 day 1, 4 weeks), while patients in the control group use paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1). Interval debulking surgery(IDS) will be performed within 3-4 weeks after 3 cycles of NACT. The primary endpoint is the proportion of Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints are progression-free survival(PFS), overall survival(OS) and the rates of complete resection and adverse events(AEs).

Official Title
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Effect of Albumin-bound Paclitaxel Plus Carboplatin Compared With Paclitaxel Plus Carboplatin in Patients Receiving Neoadjuvant Chemotherapy for Advanced Ovarian, Fallopian Tube or Peritoneal Cancer: A Phase 2 Single Center Clinical Trial

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: albumin-bound paclitaxel
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC Patients with Fagotti score ≥8 Adequate kidney function (blood creatinine 58-96 µmol/L) Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L, neutrophils ≥2.0×109/L, platelets≥100×109/L) Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT ≤1.5) World Health Organization(WHO) score 0-2 expected lifespan>12 weeks Exclusion Criteria: Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy Complicated with any other known malignancies Patients with poor cardiopulmonary function, which would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dd-nab-paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks), combined with carboplatin (AUC = 5, days 1), dd-nab TC regimen every 4 weeks will be given to the patients in study group, while for the patients in control group, paclitaxel (175 mg/m2, day 1) combined with carboplatin (AUC=6, day1) will administered.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dd-nabTC<br>albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks) combined with carboplatin (AUC = 5, day 1, every 4 weeks) | Drug: albumin-bound paclitaxel<br>* albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15, every 4 weeks) combined with carboplatin (AUC = 5 day 1, every 4 weeks)<br>|
| Active Comparator: CONTROL<br>paclitaxel (175 mg/m2, day 1, every 4 weeks) combined with carboplatin (AUC=6, day1, every 4 weeks) | Drug: paclitaxel<br>* paclitaxel (175 mg/m2, day 1, every 3 weeks) combined with carboplatin (AUC=6, day1, every 3 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemotherapy response score(CRS) 3 | the proportion of chemotherapy response score 3 | At the end of cycle 3 NACT (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | From date of randomization until the date of first documented progression, assessed up to 3 years | 
| OS | overall survival | From date of randomization until the time of death from any cause, assessed up to 3 years | 
| AEs | adverse effects of chemotherapy | during the treatment procedure |