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Because of very slow rate of enrollement
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| Name | Class |
|---|---|
| Boryung Pharmaceutical Co., Ltd | INDUSTRY |
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Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCRT weekly carboplatin | Experimental | Concurrent chemoradiation therapy with weekly carboplatin |
|
| CCRT weekly cisplatin | Active Comparator | Concurrent chemoradiation therapy with weekly cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy | Radiation | pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | 3 months after completion of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events as a measure of safety and tolerability | Before each chemotherapy, an average of 1 week | |
| Disease-free survival | 2 years after completion of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
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| Carboplatin | Drug | carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36 |
|
| Cisplatin | Drug | Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36 |
|
| Overall survival | 2 years after completion of study treatment |
| Quality of life | 3 months after completion of study treatment |
| 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 |
| D007287 |
| Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |