Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_RT Trial)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervix Cancer; Radiotherapy, Adjuvant; Radiotherapy, Intensity-Modulated; Hypofractionated Dose
• Intervention / Treatment: Radiation: POHIM-RT

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POHIM-RT; adjuvant hypofractionated IMRT for cervical cancer patients	Radiation: POHIM-RT; postoperative adjuvant IMRT with hypofractionation (2.5 Gy/fraction, 16 fractions, once a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute toxicities according to CTCAE v4.0	evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late toxicities according to CTCAE v4.0	evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0	5-years
Progression free survival rate	progression free survival rate after the time of surgery	5-years

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Won Park, M.D.,Ph.D, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Estimated): April 28, 2025
• Study Completion (Estimated): April 28, 2025

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 1, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: SMC 2017-03-092-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No