Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01594099
• Other study ID #: GCR-02
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 27, 2012
• Last updated: May 6, 2012
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2012
• Source: Xi’an Jiaotong University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Histologically proven squamous carcinoma of cervix

2. FIGO stage?B and ?B

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• irradiation
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,a/ß=10).

Drug:
• 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,a/ß=10). Chemotherapy: Cisplatin (20mg /week) will be carry out in the 2nd to 6th week during radiation therapy.
• 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,a/ß=10). Chemotherapy: Liposome paclitaxel (40mg /m2/2weeks) will be carry out in the 2nd ,4th,6th week during radiation therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xi’an Jiaotong University College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Objective Response Rate: Complete response (CR)+ Partial response (PR) rates base on RECIST evaluation system.	1 month after the treatment completed	No
Primary	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.	Yes
Secondary	Local Control Rate		Participants will be followed every year for the duration of 5 years	No
Secondary	Tumor Free Survival Rate		From date of randomization until tumor recurrence or metastasis,assessed up to 5 years	No
Secondary	Overall Survival Rate		From date of randomization until the date of death from any cause,assessed up to 5 years	No