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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cervix Cancer
• Hypofractionated Dose
• Radiotherapy, Adjuvant
• Radiotherapy, Intensity-Modulated
• Uterine Cervical Neoplasms

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