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

Phase 2
65 Years
80 Years
Open (Enrolling)
Cervical Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Objective Response Rate

Outcome Description:

Objective Response Rate: Complete response (CR)+ Partial response (PR) rates base on RECIST evaluation system.

Outcome Time Frame:

1 month after the treatment completed

Safety Issue:


Principal Investigator

Chen M W, M.D

Investigator Role:

Study Director

Investigator Affiliation:

Affiliated Hospital of Medical College of Xi'an Jiaotong University


China: Ministry of Health

Study ID:




Start Date:

April 2012

Completion Date:

March 2014

Related Keywords:

  • Cervical Cancer
  • cervical cancer
  • elderly women
  • concurrent chemotherapy
  • Uterine Cervical Neoplasms