Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

May 6, 2012 updated by: Liu Zi, Health Science Center of Xi'an Jiaotong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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，α/β=10).

Other Names:
  • RT
Experimental: Radiotherapy plus cisplatin
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，α/β=10).

Chemotherapy: Cisplatin (20mg /week) will be carry out in the 2nd to 6th week during radiation therapy.

Other Names:
  • RT+C
Experimental: Radiotherapy plus liposome paclitaxel
Drug: 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:
  • RT+Lp

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

This is where you will find people and organizations involved with this study.

Sponsor

Health Science Center of Xi'an Jiaotong University

Investigators

  • Study Director: Chen M W, M.D, Affiliated Hospital of Medical College of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

May 6, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 6, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCR-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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