NCT00842660

Brief Summary

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation. The major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone. Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2009

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 5, 2010

Status Verified

February 1, 2009

Enrollment Period

2.9 years

First QC Date

February 8, 2009

Last Update Submit

January 3, 2010

Conditions

Cervical Cancer

Keywords

Cervical cancerconcurrent chemoradiotherapygemcitabine

Outcome Measures

Primary Outcomes (1)

  • Patient survival, including overall survival and progression-free survival.

    2012,

Secondary Outcomes (1)

  • 1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life

    2013

Study Arms (1)

Gemzar,survival

EXPERIMENTAL
Drug: Gemzar (gemcitabine)

Interventions

Gemzar (gemcitabine)DRUG

Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride

Also known as: GEMCITABINE
Gemzar,survival

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed primary squamous cell carcinoma of the uterine cervix.
  • Previously untreated disease.
  • Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET examination.
  • No known metastases to supraclavicular nodes or other organs outside the radiotherapy field.
  • Ages eligible: 35 years - 70 years.
  • Patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. WBC \> 3000/mm3, platelet \> 100,000/mm3, serum transaminases (GOT, GPT) \< 60 IU/ml, total bilirubin \< 1.5mg%, creatinine \< 1.4mg% (creatinine clearance \> 60 ml/min).
  • Performance status 0 or 1 (see Appendix I).
  • The interval between RT and randomization is not greater than 3 weeks.
  • Patients must have signed informed consent to participate this study.

You may not qualify if:

  • Age \> 70 or \< 35
  • Medical or psychological condition that would preclude treatment.
  • Previous chemotherapy or pelvic RT.
  • Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
  • Patient unreliable for treatment completion and follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chong Jong Wang,

Kaohsiung City, M.D, Taiwan

Location

Chien-Sheng Tsai

Keelung, Taiwan

Location

Related Publications (1)

  • Wang CC, Chou HH, Yang LY, Lin H, Liou WS, Tseng CW, Liu FY, Liou JD, Huang KG, Huang HJ, Huang EY, Chen CH, Chang TC, Chang CJ, Hong JH, Lai CH. A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer: An Asian Gynecologic Oncology Group study. Gynecol Oncol. 2015 Jun;137(3):462-7. doi: 10.1016/j.ygyno.2015.03.046. Epub 2015 Mar 28.

    PMID: 25827291DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Chun Chieh Wang, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2009

First Posted

February 12, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

January 5, 2010

Record last verified: 2009-02

Locations

TW(2)