Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

Phase 2

• Conditions: Cervical Cancer
• Interventions: Radiation: irradiation; Drug: liposome paclitaxel; Drug: Cisplatin

• Registration Number: NCT01594099
• Lead Sponsor: Health Science Center of Xi'an Jiaotong University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-03-27
• Study Start: 2012-04
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-06
• Last Update Submitted: 2012-05-06
• Study First Posted: 2012-05-08
• Last Update Posted: 2012-05-08
• Primary Completion: 2013-10
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy alone	irradiation	-
Radiotherapy plus liposome paclitaxel	liposome paclitaxel	-
Radiotherapy plus cisplatin	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	1 month after the treatment completed	Objective Response Rate: Complete response (CR)+ Partial response (PR) rates base on RECIST evaluation system.
Adverse Events	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

Secondary Outcome Measures

Name	Time	Method
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