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| Name | Class |
|---|---|
| Jilin Provincial Tumor Hospital | OTHER |
| Affiliated Hospital of Hebei University | OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
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Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiotherapy | Radiation | Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (objective response rate) | ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants | the 1, 3, 6, 9, 12 months after the end of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| AE | adverse events | the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment |
| OS | objective response rate | the 1, 2, and 3 years after the end of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Jiang, doctor | Contact | 86010-82266699 | jiangping@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ping Jiang, Doctor | Peking University Third Hospital | Principal Investigator |
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Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin
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| Nab paclitaxel | Drug | Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week). |
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| Cisplatin | Drug | Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m^2) and weekly nab-paclitaxel at escalating doses (33 mg/m^2 per week). |
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| PFS | progression-free survival | the 1, 2, and 3 years after the end of the treatment |
| DOR | duration of response | the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment |
| DCR | disease control rate | the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment |
| CBR | clinical benefit rate | the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013660 | Taxes |
| D017239 | Paclitaxel |
| D007267 | Injections |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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