CClinicalTrials.gg
Status unknownNCT01487226Updated Dec 7, 2011

Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer

A Phase 2 interventional study of paclitaxel and Cisplatin 50mg/m2 in Cervical Cancer, sponsored by Korean Gynecologic Oncology Group. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-12-07.

Sponsored by Korean Gynecologic Oncology Group · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
Female
01

Study summary

Purpose Primary endpoint

  • To evaluate the 3-year disease free survival Second endpoints
  • To evaluate the 3-year \& 5-year overall survival To analyze the toxicity and the quality of life
02

Conditions studied

  • Cervical Cancer

Keywords

  • Cervical cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 69 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Korean Gynecologic Oncology Group is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • cervical cancer stage Ia2-IIa
  • histology; squamous, adeno, adenosquamous subtype
  • age; 20∼70 years
  • performance status; GOG 0∼2
  • no medical illness
  • hematologic, renal, hepatic function; normal
  • grossly no residual disease
  • histologically confirmed lymph nodes metastases
  • no parametrial extension and negative resection margin
  • number of retrieved lymph nodes; ≥ 20

Exclusion criteria

Exclusion Criteria:

  • patients with grade 2 peripheral neuropathy
  • patients with uncontrolled infection
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (estimated)

Interventions

  • Drugpaclitaxel

    Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks \* 6 cycles

  • DrugCisplatin 50mg/m2

    Cisplatin 50mg/m2 Repeat every 3 weeks \* 6 cycles

    Also known as: Cisplatin

06

What researchers measure

Primary outcomes

  1. Kaplan-Meier

Secondary outcomes

  1. log-rank test Cox regression analysis

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01487226
Lead sponsor
Korean Gynecologic Oncology Group
Responsible party
Taek Sang Lee (Principal Investigator, Korean Gynecologic Oncology Group) — Principal investigator
First posted
Dec 7, 2011
Start date
Jan 2008
Primary completion
Jan 2015 (estimated)
Completion
Jan 2015 (estimated)
Last update
Dec 7, 2011

Study contacts

Eunkyung Park
Contact
koreagynonco@gmail.com
8225125420
Jong Min Lee, MD
principal investigator · Kyung-Hee University East-West Med. Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion