Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women
This trial is active, not recruiting.
|Treatments||irradiation, cisplatin, liposome paclitaxel|
|Sponsor||Xi’an Jiaotong University College of Medicine|
|Start date||April 2012|
|End date||October 2013|
|Trial size||45 participants|
|Trial identifier||NCT01594099, GCR-02|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Objective Response Rate
time frame: 1 month after the treatment completed
time frame: Participants will be followed from the treatment begin to 1 month after the treatment end.
Local Control Rate
time frame: Participants will be followed every year for the duration of 5 years
Tumor Free Survival Rate
time frame: From date of randomization until tumor recurrence or metastasis,assessed up to 5 years
Overall Survival Rate
time frame: From date of randomization until the date of death from any cause,assessed up to 5 years
Female participants from 65 years up to 80 years old.
Inclusion Criteria: 1. Histologically proven squamous carcinoma of cervix 2. FIGO stageⅡB and ⅢB 3. Over 65 years 4. Do not receive other treatment 5. Performance index ECOG grade 0 to 2 6. Normal ECG 7. Normal hematological parameters 8. Normal renal and liver function tests Exclusion Criteria: 1. Concomitant disease which may adversely affect the outcome 2. Poor nutritional status 3. Medical or psychological condition precluding treatment 4. Previous treatment 5. Concurrent treatment for any cancer
|Official title||Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer|
|Description||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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