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

A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00373620

Enrollment

Registered

2006-09-08

Start date

2006-01-31

Completion date

Unknown

Last updated

2006-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

endometrial cancer, high risk, weekly paclitaxel, Cuncurrent chemoradiation

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.

Detailed description

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.

Interventions

DRUGpaclitaxel

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Two year progression free survival	—

Secondary

Measure	Time frame
toxicity profile	—

Countries

South Korea

Contacts

Primary ContactJae-Hoon Kim, Professor

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

Backup ContactHyun Hoon Chung, Fellow

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026