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A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients

NCT ID: NCT00373620

Last Updated: 2006-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to improve survival. Paclitaxel (P) has shown in vitro and clinical activity against endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in G2/M phase. This study is to evaluate the efficacy and safety of a treatment with concomitant weekly chemotherapy with paclitaxel and RT in high risk advanced endometrial cancer.

Conditions

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Endometrial Cancer

Keywords

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endometrial cancer high risk weekly paclitaxel Cuncurrent chemoradiation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Korean Gynecologic Oncology Group

OTHER

Sponsor Role lead

Principal Investigators

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Jae-Hoon Kim, Professor

Role: STUDY_CHAIR

Yong-Dong Severance Hospital

Locations

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Young-Dong Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae-Hoon Kim, Professor

Role: CONTACT

Phone: +82-2-2019-3436

Email: [email protected]

Hyun Hoon Chung, Fellow

Role: CONTACT

Phone: +82-2-2072-2821

Email: [email protected]

Facility Contacts

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Jae-Hoon Kim, Professor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25015202 (View on PubMed)

Other Identifiers

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KGOG2001

Identifier Type: -

Identifier Source: org_study_id