Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2017
CompletedFirst Posted
Study publicly available on registry
August 4, 2017
CompletedStudy Start
First participant enrolled
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2023
CompletedJanuary 3, 2025
November 1, 2023
5.7 years
August 2, 2017
January 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Acute toxicities according to CTCAE v4.0
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
3 months
Secondary Outcomes (2)
Late toxicities according to CTCAE v4.0
5-years
Progression free survival rate
5-years
Study Arms (1)
POHIM-CCRT
OTHERpostoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Interventions
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
Related Publications (1)
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.
PMID: 38662364DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2017
First Posted
August 4, 2017
Study Start
August 31, 2017
Primary Completion
April 28, 2023
Study Completion
April 28, 2023
Last Updated
January 3, 2025
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share