Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

NCT01594099 | Unknown Phase 2 DMC

• 1 other identifier: GCR-02
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer

Keywords

cervical cancer; elderly women; concurrent chemotherapy

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

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

  1 month after the treatment completed

• Adverse Events

  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 Outcomes (3)

• 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

Study Arms (3)

Radiotherapy alone

ACTIVE COMPARATOR

Radiation: irradiation

Radiotherapy plus cisplatin

EXPERIMENTAL

Drug: Cisplatin

Radiotherapy plus liposome paclitaxel

EXPERIMENTAL

Drug: liposome paclitaxel

Interventions

irradiation RADIATION

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).

Also known as: RT

Radiotherapy alone

Cisplatin DRUG

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.

Also known as: RT+C

Radiotherapy plus cisplatin

liposome paclitaxel DRUG

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.

Also known as: RT+Lp

Radiotherapy plus liposome paclitaxel

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically proven squamous carcinoma of cervix
• FIGO stageⅡB and ⅢB
• Over 65 years
• Do not receive other treatment
• Performance index ECOG grade 0 to 2
• Normal ECG
• Normal hematological parameters
• Normal renal and liver function tests

You may not qualify if:

• Concomitant disease which may adversely affect the outcome
• Poor nutritional status
• Medical or psychological condition precluding treatment
• Previous treatment
• Concurrent treatment for any cancer

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiation; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Chen M W, M.D

  Affiliated Hospital of Medical College of Xi'an Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: May 8, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 8, 2012

Record last verified: 2012-05