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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-GYN/CC-01 | Other Identifier | Tongji Hospital, HUST |
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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| Shandong University | OTHER |
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We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Chemotherapy (Arm A) | Experimental | Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary. |
|
| Concurrent radiochemotherapy, CCRT (Arm B) | Active Comparator | Pelvic RT is delivered using IMRT technique, 45~50.4 Gy/4~7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radical hysterectomy + pelvic lymph node dissection | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival (DFS) | DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence. | up to 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survivals (OS) | 3-year | |
| Quality of Life in two arms | 3 years | |
| chemotherapy- and radiotherapy- related adverse effects respectively in two arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ding Ma, MD, PhD | Huazhong University of Science and Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36422763 | Background | Weng D, Xiong H, Zhu C, Wan X, Chen Y, Wang X, Zhang Y, Jiang J, Zhang X, Gao Q, Chen G, Xing H, Wang C, Li K, Chen Y, Mao Y, Hu D, Pan Z, Chen Q, Cui B, Song K, Yi C, Peng G, Han X, An R, Fan L, Wang W, Xiong T, Chen Y, Tang Z, Li L, Yang X, Cheng X, Lu W, Wang H, Kong B, Xie X, Ma D. Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial. Front Med. 2023 Feb;17(1):93-104. doi: 10.1007/s11684-021-0892-z. Epub 2022 Nov 23. |
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| Paclitaxel |
| Drug |
135-175 mg/m(2) intravenously (IV) on day 1 |
|
| Cisplatin | Drug | 75 mg/m(2) IV on day 2 and 3 |
|
| Cisplatin | Drug | 35 mg/m(2) IV once a week |
|
| Pelvic RT | Radiation | IMRT |
|
| 3 years |
| Qilu Hospital, Shandong University |
| Jinan |
| Shandong |
| 250012 |
| China |
| Women's Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
| 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 |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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