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Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Liu Zi, Xi'an Jiaotong University College of Medicine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594099
First Posted: May 8, 2012
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Liu Zi, Xi'an Jiaotong University College of Medicine
  Purpose
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.

Condition Intervention Phase
Cervical Cancer Radiation: irradiation Drug: Cisplatin Drug: liposome paclitaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weekly Cisplatin or Weekly Liposome Paclitaxel Concurrent Radiation Therapy in Treating Elderly People With Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Liu Zi, Xi'an Jiaotong University College of Medicine:

Primary Outcome Measures:
  • 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.

  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: RT+Lp

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.
  Eligibility

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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594099


Sponsors and Collaborators
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
  More Information

Responsible Party: Liu Zi, Profesor, Xi'an Jiaotong University College of Medicine
ClinicalTrials.gov Identifier: NCT01594099     History of Changes
Other Study ID Numbers: GCR-02
First Submitted: March 27, 2012
First Posted: May 8, 2012
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Liu Zi, Xi'an Jiaotong University College of Medicine:
cervical cancer
elderly women
concurrent chemotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action