Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women
Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Radiotherapy alone
|
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).
Other Names:
|
|
Experimental: Radiotherapy plus cisplatin
|
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.
Other Names:
|
|
Experimental: Radiotherapy plus liposome paclitaxel
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate
Time Frame: 1 month after the treatment completed
|
Objective Response Rate: Complete response (CR)+ Partial response (PR) rates base on RECIST evaluation system.
|
1 month after the treatment completed
|
|
Adverse Events
Time Frame: Participants will be followed from the treatment begin to 1 month after the treatment end.
|
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 |
Time Frame |
|---|---|
|
Local Control Rate
Time Frame: Participants will be followed every year for the duration of 5 years
|
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
|
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
|
From date of randomization until the date of death from any cause,assessed up to 5 years
|
Collaborators and Investigators
Investigators
- Study Director: Chen M W, M.D, Affiliated Hospital of Medical College of Xi'an Jiaotong University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- GCR-02
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