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Active, not recruiting Not applicable

Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

NCT03239626 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2017-08-31
Last updated
2025-01-03

Condition(s) studied

Cervix CancerRadiotherapy, AdjuvantRadiotherapy, Intensity-ModulatedHypofractionated Dose

Investigational drug(s) / intervention(s)

POHIM-RT

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

Study 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.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
70 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03239626 on ClinicalTrials.gov ↗ ← All trials in South Korea