Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer

November 22, 2023 updated by: Samsung Medical Center

Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Exploratory Trial (POHIM_CCRT Trial)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 chemoradiotherapy (more than one as below)

    • positive pelvic lymph node metastasis
    • positive parametrial invasion
    • positive tumor involvement on surgical margin
  • ECOG performance status 0 or 1
  • Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl
  • Kidney function: Creatinine <2.0 mg/dL, Bilirubin 1.5 mg/dl

Exclusion Criteria:

  • positive distant metastasis (including retroperitoneal lymph node metastasis)
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: POHIM-CCRT
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Other: POHIM-CCRT
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (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
Time Frame: 3 months
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2017

Primary Completion (Estimated)

April 28, 2024

Study Completion (Estimated)

April 28, 2024

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)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2017-03-091-003

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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