NCT00373620

Brief Summary

The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial cancer patients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

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

January 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
Last Updated

September 8, 2006

Status Verified

December 1, 2005

First QC Date

September 6, 2006

Last Update Submit

September 6, 2006

Conditions

Endometrial Cancer

Keywords

endometrial cancerhigh riskweekly paclitaxelCuncurrent chemoradiation

Outcome Measures

Primary Outcomes (1)

  • Two year progression free survival

Secondary Outcomes (1)

  • toxicity profile

Interventions

paclitaxelDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undertaken total hysterectomy, bilateral salpingoophorectomy, washing cytology, pelvic and paraaortic lymph node dissection
  • Patients must have the diagnosis of endometrioid type adenocarcinoma with stage III, IV.
  • Patients must have a GOG performance of 0, 1, or 2.
  • Patients must have expected life span over 6 months.

You may not qualify if:

  • Patients with peripheral neurotoxicity over grade 2 in CTC criteria.
  • Patients with history of chemotherapy or radiation treatment.
  • patients with history of arrhythmia,congestive heart failure.
  • Patients with intractable infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Young-Dong Severance Hospital

Seoul, 135-720, South Korea

RECRUITING

Related Publications (1)

  • Cho H, Nam BH, Kim SM, Cho CH, Kim BG, Ryu HS, Kang SB, Kim JH. A phase 2 trial of radiation therapy with concurrent paclitaxel chemotherapy after surgery in patients with high-risk endometrial cancer: a Korean Gynecologic Oncologic Group study. Int J Radiat Oncol Biol Phys. 2014 Sep 1;90(1):140-6. doi: 10.1016/j.ijrobp.2014.05.024. Epub 2014 Jul 8.

    PMID: 25015202DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Jae-Hoon Kim, Professor

    Yong-Dong Severance Hospital

    STUDY CHAIR

Central Study Contacts

Jae-Hoon Kim, Professor

CONTACT

+82-2-2019-3436jaehoonkim@yumc.yonsei.ac.kr

Hyun Hoon Chung, Fellow

CONTACT

+82-2-2072-2821chhkmj1@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

January 1, 2006

Last Updated

September 8, 2006

Record last verified: 2005-12

Locations

KR(1)