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The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced cervical cancer in elderly women.
Concurrent radiotherapy is the standard treatment of inoperable cervical cancer .Due to the physical conditions, elderly patients usually associated with medical complications, so generally just receive radiotherapy alone. Recently, some retrospective studies have shown that the impact of chemotherapy did not cause an increase in the complication rate among elderly patients as compared to younger patients with cervical cancer, and may improve the survival when concurrent with radiotherapy. Cisplatin and paclitaxel are two effective drug in treating cervical cancer, but whether they are safe enough for elderly when concurrent with radiotherapy, there are no clearly reports. In this study ,we replace the conventional dose chemotherapy with weekly cisplatin or lipsome paclitaxel , to compare the efficiency and safety of weekly cisplatin / liposome paclitaxel concurrent chemoradiotherapy and radiotherapy alone in the treatment of cervical cancer in elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy alone | Active Comparator |
| |
| Radiotherapy plus cisplatin | Experimental |
| |
| Radiotherapy plus liposome paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irradiation | Radiation | EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border:branching of abdominal aorta. Lower border: the inferior margin of obturator foramen. Brachytherapy :Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy,α/β=10). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate: Complete response (CR)+ Partial response (PR) rates base on RECIST evaluation system. | 1 month after the treatment completed |
| Adverse Events | Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 | Participants will be followed from the treatment begin to 1 month after the treatment end. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate | Participants will be followed every year for the duration of 5 years | |
| Tumor Free Survival Rate | From date of randomization until tumor recurrence or metastasis,assessed up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen M W, M.D | Affiliated Hospital of Medical College of Xi'an Jiaotong University | Study Director |
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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 |
|---|---|
| D011827 | Radiation |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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|
|
| Cisplatin | Drug | EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border:branching of abdominal aorta. Lower border: the inferior margin of obturator foramen. Brachytherapy: Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy,α/β=10). Chemotherapy: Cisplatin (20mg /week) will be carry out in the 2nd to 6th week during radiation therapy. |
|
|
| liposome paclitaxel | Drug | EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border:branching of abdominal aorta. Lower border: the inferior margin of obturator foramen. Brachytherapy: Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy,α/β=10). Chemotherapy: Liposome paclitaxel (40mg /m2/2weeks) will be carry out in the 2nd ,4th,6th week during radiation therapy. |
|
|
| Overall Survival Rate | From date of randomization until the date of death from any cause,assessed up to 5 years |
| 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 |
| D017671 |
| Platinum Compounds |