NCT00591656

Brief Summary

The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following primary chemoradiation for locally advanced cervical cancer.

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
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 11, 2008

Status Verified

December 1, 2007

Enrollment Period

2 years

First QC Date

December 31, 2007

Last Update Submit

December 31, 2007

Conditions

Cervical Cancer

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Care clinic

You may qualify if:

  • patients who underwent three cycles of concurrent chemoradiation therapy with paclitaxel and carboplatin for non-small cell type cervical cancer stage IB2, bulky size (\>4cm) IIA,IIB-IVA
  • above 20 years
  • GOG performance status 0-2
  • Informed consent
  • Platelet\>100K, Hb\> 10.0 g/dl, ANC\>1500/mm3, Cr \<1.25\*upper normal limit, bilirubin\<1.5mg/dl, AST \& ALT\<\*3 upper normal limit
  • Expected life \> 6 months

You may not qualify if:

  • Peripheral neurotoxicity \> NCI CTCAE grade 2
  • Sever infection
  • Previous history with chemotherapy or radiation therapy
  • Pleural effusion, pericardial effusion, and ascites which could cause dyspnea \> NCI grade 2
  • Paraaortic lymph node metastasis
  • Allergy with platinum
  • Previous history of atrial or ventricular arrhythmia or congestive heart failure
  • Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months
  • Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

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

  • Jae Weon Kim, Professor

    Seoul National University Hospital

    STUDY DIRECTOR

  • Seung Su Han, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 11, 2008

Study Start

November 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2012

Last Updated

January 11, 2008

Record last verified: 2007-12

Locations

KR(1)