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This is a randomized, multicenter, open, controlled Post-Marketing Study. 396 patients who were histopathology or exfoliated cell pathology of pleural and ascites confirmed with epithelial ovarian cancer/fallopian tube/peritoneal cancer were enrolled in this study. The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and the stratification factors included: chemotherapy type (adjuvant chemotherapy/neoadjuvant chemotherapy), residual disease after surgery (>1cm, <1cm, no primary surgery), stage (Ic, II, III or IV), pathological typing, Eastern Cooperative Oncology Group performance status (0 to 1 or 2), BRCA1/2 gene mutation.
Subjects will receive one of two treatment regimens:
Group A: intravenous infusion of liposomal doxorubicin 30 mg/m2, d1; carboplatin AUC 5 (dosed according to the Calvert formula, with creatinine clearance estimated according to the Cockcroftformula), intravenous infusion, d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage.
Group B: intravenous infusion of paclitaxel 175 mg/m2, d1; carboplatin AUC 5, intravenous infusion, d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage. Treatment was initially administered for three cycles, and patients with stable or responding disease continued treatment for further a three cycles.
The main purpose is to evaluate the efficacy and safety of liposomal doxorubicin plus carboplatin in the first-line treatment of epithelial ovarian cancer. The primary endpoint is progression free survival (PFS), the secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR):CR+PR+SD, the incidence and severity of adverse reactions and health-related quality of life (HQL) assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | pegylated liposomal doxorubicin 30 mg/m2, i.v.,d1; carboplatin AUC 5,i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage. |
|
| chemotherapy | Active Comparator | paclitaxel 175 mg/m2, i.v.,d1; carboplatin AUC 5, i.v.,d1; once every 21days, 3~6 cycles for early stage patients and 6 cycles for late stage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated liposomal doxorubicin | Drug | PLD 30 mg/m2, i.v.,d1; once every 21days |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. | From date of randomization until the date of first documented progression or death from any cause, whichever occurred first, or last follow-up for patients alive without progression, assessed up to approximately 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | From date of randomization until the date of death from any cause, or date of last follow-up for patients still alive, assessed up to 36 months |
| ORR | ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. Activity was also described in women with nontarget lesions only and in women without any tumor lesion but with elevated CA-125 levels before starting treatment. |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School Of Medicine Zhejiang University | Zhejiang | Hangzhou | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41709925 | Derived | Shen Y, Tu N, Kong B, Xia B, Zou Y, Yin R, Li Q, Yue Y, Kang S, Wang K, He L, Wang S, Meng Y, Qu P, Huang X, Guo R, Yan P, Pan M, Cheng W, Lou G, Wang Z. Pegylated liposomal doxorubicin plus carboplatin versus paclitaxel plus carboplatin as first-line therapy for epithelial ovarian cancer (CGCS-04): a multicenter, randomized clinical trial. Ther Adv Med Oncol. 2026 Feb 16;18:17588359261420402. doi: 10.1177/17588359261420402. eCollection 2026. |
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| paclitaxel | Drug | paclitaxel 175 mg/m2, i.v.,d1; once every 21days |
|
|
| Carboplatin | Drug | carboplatin AUC 5, i.v.,d1; once every 21days, |
|
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| From date of randomization until PD or death from any cause, assessed up to 36 months. |
| DCR | DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1. | From date of randomization until PD or death from any cause, assessed up to 36 months. |
| the incidence and severity of adverse reactions | Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment. | A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 36 months. |
| quality of life assessment | according to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30).The basic content of life quality assessment includes: physical health, mental health, social function, disease status and overall health perception. | It will be assessed at baseline and before the administration of drugs at each first day of every two chemotherapy cycles, up to 6 cycles,each cycle is 21 days. |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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