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NCT03239626 Clinical Trial

Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

Cervix Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03239626
Other study ID # SMC 2017-03-092-002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 31, 2017
Est. completion date April 28, 2025

Study information
Verified date November 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date April 28, 2025
Est. primary completion date April 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Radiation:
• POHIM-RT
postoperative adjuvant IMRT with hypofractionation (2.5 Gy/fraction, 16 fractions, once a day)

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary acute toxicities according to CTCAE v4.0 evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0 3 months
Secondary late toxicities according to CTCAE v4.0 evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0 5-years
Secondary Progression free survival rate progression free survival rate after the time of surgery 5-years
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