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NCT Number: NCT05876130

Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

To investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 Gy x 16 fractions) after curative surgery for stage III endometrial cancer.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Location status: Recruiting

Location contact

Won Park

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologically confirmed endometrioid type endometrial cancer
  • completion of hysterectomy and surgical staging
  • pathologically confirmed FIGO stage III
  • ECOG performance status 0 or 1
  • adjuvant chemotherapy was done or planned

Exclusion criteria

  • presence of distant metastasis
  • previous history of pelvic radiotherapy
  • severe and unstable medical condition
  • previous history of other carcinoma except for thyroid cancer, skin cancer, and endometrial cancer

Treatment and study plan

POHIM_EM

Radiation

hypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions)

Primary outcomes

  1. 5-year disease-free survival rate

    Time frame: 5 years

    disease-free survival rate after the time of surgery

Secondary outcomes

  1. acute toxicities

    Time frame: 3 months

    acute toxicities within 3 months according to CTCAE v5.0

  2. late toxicities

    Time frame: 5 years

    late toxicities according to CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Won Kyung Cho

CONTACT

[email protected]

Won Park

CONTACT

[email protected]

+82-2-3410-2612

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
May 25, 2023
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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