Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatments irradiation, cisplatin, liposome paclitaxel
Phase phase 2
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
irradiation RT
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).
(Experimental)
cisplatin RT+C
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.
(Experimental)
liposome paclitaxel RT+Lp
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.

Primary Outcomes

Measure
Objective Response Rate
time frame: 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.

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Xi’an Jiaotong University College of Medicine.