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

Not Applicable

Completed

• Conditions: Cervix Cancer; Radiotherapy, Adjuvant; Radiotherapy, Intensity-Modulated; Chemotherapy, Concurrent; Hypofractionated Dose
• Interventions: Other: POHIM-CCRT

• Registration Number: NCT03239613
• 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 concurrent chemotherapy with 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
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2023-11
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POHIM-CCRT	POHIM-CCRT	postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)

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

Trial Locations

Locations (1)

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