Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Radiation: irradiation
* Drug: Cisplatin
* Drug: liposome paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven squamous carcinoma of cervix FIGO stageⅡB and ⅢB Over 65 years Do not receive other treatment Performance index ECOG grade 0 to 2 Normal ECG Normal hematological parameters Normal renal and liver function tests Exclusion Criteria: Concomitant disease which may adversely affect the outcome Poor nutritional status Medical or psychological condition precluding treatment Previous treatment Concurrent treatment for any cancer

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiotherapy alone<br> | Radiation: irradiation<br>* 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).<br>* Other names: RT;|
| Experimental: Radiotherapy plus cisplatin<br> | Drug: Cisplatin<br>* 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.<br>* Other names: RT+C;|
| Experimental: Radiotherapy plus liposome paclitaxel<br> | Drug: liposome paclitaxel<br>* 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.<br>* Other names: RT+Lp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Overall Survival Rate |  | From date of randomization until the date of death from any cause,assessed up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, elderly women, concurrent chemotherapy