NCT00950261

Brief Summary

The standard postoperative treatment for patients with cervical cancer who had high-risk factors is chemoradiation. Generally, weekly cisplatin or 5FU+cisplatin every 3 week have been used as chemotherapy regimens of chemoradiation. Based on their experience, the investigators hypothesized that tri-weekly cisplatin could be superior to weekly cisplatin. Therefore, the investigators are going to perform the efficacy study of postoperative, tri-weekly cisplatin chemoradiation for patients with cervical cancer.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

July 30, 2009

Last Update Submit

August 9, 2018

Conditions

Cervical Neoplasms

Keywords

Cervical neoplasmsCisplatinConcurrent Chemoradiation

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    2 year

Secondary Outcomes (4)

  • overall survival

    2 year

  • disease-free survival

    5 year

  • overall survival

    5 year

  • all kinds of toxicity

    during treatment

Study Arms (1)

tri-weekly cisplatin

EXPERIMENTAL

Patients in this arm will postoperatively receive cisplatin 75mg/m2 intravenously every 3 weeks, 3 cycles with radiation

Radiation: tri-weekly cisplatin

Interventions

tri-weekly cisplatinRADIATION

cisplatin 75mg/m2 every 3 weeks, intravenous, 3 cycles

tri-weekly cisplatin

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cervical cancer
  • underwent radical hysterectomy
  • non-small cell type
  • FIGO stage 1B - 2A
  • have one or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
  • GOG performance status 0 - 2

You may not qualify if:

  • Previous history of chemotherapy or radiation
  • History of other cancer
  • Hypersensitivity to platinum agents
  • Pregnancy
  • Serious medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea Institute of Radiological & Medical Sciences

Seoul, 139-706, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sang-Young Ryu, MD

    Korea Institute of Radiological & Medical Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Cerivcal/Ovarian Cancer Center

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

KR(1)