Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer
NCT ID: NCT03239613
Last Updated: 2025-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2017-08-31
2023-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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POHIM-CCRT
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
POHIM-CCRT
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Interventions
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POHIM-CCRT
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
FEMALE
Yes
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Cho WK, Park W, Kim SW, Lee KK, Ahn KJ, Choi JH. Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer: The POHIM-CCRT Nonrandomized Controlled Trial. JAMA Oncol. 2024 Jun 1;10(6):737-743. doi: 10.1001/jamaoncol.2024.0565.
Other Identifiers
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SMC 2017-03-091-003
Identifier Type: -
Identifier Source: org_study_id
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