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Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
POHIM-RT
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervix Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

POHIM-RT

Arm Description

adjuvant hypofractionated IMRT for cervical cancer patients

Outcomes

Primary Outcome Measures

acute toxicities according to CTCAE v4.0
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0

Secondary Outcome Measures

late toxicities according to CTCAE v4.0
evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0
Progression free survival rate
progression free survival rate after the time of surgery

Full Information

First Posted
August 2, 2017
Last Updated
July 7, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03239626
Brief Title
Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer
Official Title
Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer: A Prospective Exploratory Trial (POHIM_RT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
April 28, 2025 (Anticipated)
Study Completion Date
April 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Hypofractionated Dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group for hypofractionaed IMRT for adjvuant cervical cancer patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
POHIM-RT
Arm Type
Experimental
Arm Description
adjuvant hypofractionated IMRT for cervical cancer patients
Intervention Type
Radiation
Intervention Name(s)
POHIM-RT
Intervention Description
postoperative adjuvant IMRT with hypofractionation (2.5 Gy/fraction, 16 fractions, once a day)
Primary Outcome Measure Information:
Title
acute toxicities according to CTCAE v4.0
Description
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
Time Frame
3 months
Secondary Outcome Measure Information:
Title
late toxicities according to CTCAE v4.0
Description
evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0
Time Frame
5-years
Title
Progression free survival rate
Description
progression free survival rate after the time of surgery
Time Frame
5-years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: histologically confirmed cervical cancer radical hysterectomy and pelvic lymph node dissection was done histologically indicated adjuvant radiotherapy ( more than one as below) tumor size ≥4 cm positive lymphovascular invasion 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Park, M.D., Ph.D
Phone
+82-10-9933-2616
Email
wonro.park@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Park, M.D.,Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Park, M.D.,Ph.D
Phone
+82-2-3410-2616
Email
wonro.park@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

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