Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

Not Applicable

Active, not recruiting

• Conditions: Hypofractionated Dose; Cervix Cancer; Radiotherapy, Intensity-Modulated; Radiotherapy, Adjuvant
• Interventions: Radiation: POHIM-RT

• Registration Number: NCT03239626
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-04
• Study Start: 2017-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-04-28
• Study Completion: 2025-04-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POHIM-RT	POHIM-RT	adjuvant hypofractionated IMRT for cervical cancer patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progression free survival rate	5-years	progression free survival rate after the time of surgery
late toxicities according to CTCAE v4.0	5-years	evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of