Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

NCT ID: NCT03239626

Last Updated: 2025-01-03

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2025-04-28

Brief Summary

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To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.

Detailed Description

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Conditions

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Cervix Cancer Radiotherapy, Adjuvant Radiotherapy, Intensity-Modulated Hypofractionated Dose

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One group for hypofractionaed IMRT for adjvuant cervical cancer patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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POHIM-RT

adjuvant hypofractionated IMRT for cervical cancer patients

Group Type EXPERIMENTAL

POHIM-RT

Intervention Type RADIATION

postoperative adjuvant IMRT with hypofractionation (2.5 Gy/fraction, 16 fractions, once a day)

Interventions

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POHIM-RT

postoperative adjuvant IMRT with hypofractionation (2.5 Gy/fraction, 16 fractions, once a day)

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed cervical cancer
* radical hysterectomy and pelvic lymph node dissection was done
* histologically indicated adjuvant radiotherapy ( more than one as below)

1. tumor size ≥4 cm
2. positive lymphovascular invasion
3. more than half stromal invasion depth
* ECOG performance status 0 or 1
* Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl

Exclusion Criteria

* positive pelvic lymph node metastasis
* positive distant metastasis (including retroperitoneal lymph node metastasis)
* positive tumor involvement on resection margin
* positive parametrial invasion
* previous history of pelvic radiotherapy
* more than 3 months after radical surgery for cervical cancer
* neoadjuvant chemotherapy was done
* previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Won Park, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Cho WK, Park W, Kim SW, Lee KK, Ahn KJ, Yoon M, Choi JH. Postoperative hypofractionated intensity-modulated radiation therapy in cervical cancer: prospective phase 2 trial (POHIM_RT study). Gynecol Oncol. 2025 Jul;198:84-89. doi: 10.1016/j.ygyno.2025.05.020. Epub 2025 May 30.

Reference Type DERIVED
PMID: 40449127 (View on PubMed)

Other Identifiers

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SMC 2017-03-092-002

Identifier Type: -

Identifier Source: org_study_id

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