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Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Liu Zi, Xi'an Jiaotong University College of Medicine
ClinicalTrials.gov Identifier:
NCT01594099
First received: March 27, 2012
Last updated: May 6, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Xi’an Jiaotong University College of Medicine:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 1 month after the treatment completed ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Tumor Free Survival Rate [ Time Frame: From date of randomization until tumor recurrence or metastasis,assessed up to 5 years ] [ Designated as safety issue: No ]
  • Overall Survival Rate [ Time Frame: From date of randomization until the date of death from any cause,assessed up to 5 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594099

Sponsors and Collaborators
Xi’an Jiaotong University College of Medicine
Investigators
Study Director: Chen M W, M.D Affiliated Hospital of Medical College of Xi'an Jiaotong University
  More Information

No publications provided

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
Study First Received: March 27, 2012
Last Updated: May 6, 2012
Health Authority: China: Ministry of Health

Keywords provided by 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
Cisplatin
Paclitaxel
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013