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Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.
This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| weekly cisplatin | Active Comparator | Weekly cisplatin 40mg/m2 during radiation therapy |
|
| tri-weekly cisplatin | Experimental | cisplatin 75mg/m2 three cycles, every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation | Radiation | radiation with cisplatin 40mg/m2, 6 cycles, every week |
|
| Measure | Description | Time Frame |
|---|---|---|
| compliance |
| 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| survival |
| 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Young Ryu, MD | Korea Institute of Radiological & Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea Institute of Radiological & Medical Sciences | Seoul | 139-706 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21840137 | Result | Ryu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, Choi SC, Cho CK, Nam BH, Lee ED. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e577-81. doi: 10.1016/j.ijrobp.2011.05.002. Epub 2011 Aug 11. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| weekly cisplatin | Drug | weekly cisplatin 40mg/m2, 6 cycles |
|
|
| tri-weekly cisplatin | Drug | cisplatin 75mg/m2, 3cycles, every 3 weeks |
|
|
| 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 |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D017671 |
| Platinum Compounds |