Back to resultsPostoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer
Primary Purpose
Cervix Cancer, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
POHIM-CCRT
Sponsored by
About this trial
This is an interventional treatment trial for Cervix Cancer
Eligibility Criteria
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
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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
POHIM-CCRT
Arm Description
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Outcomes
Primary Outcome Measures
Acute toxicities according to CTCAE v4.0
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
Secondary Outcome Measures
Late toxicities according to CTCAE v4.0
evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0
Progression free survival rate
progression free survival rate after the time of surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03239613
Brief Title
Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer
Official Title
Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Exploratory Trial (POHIM_CCRT Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
April 28, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Hypofractionated Dose, Chemotherapy, Concurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POHIM-CCRT
Arm Type
Other
Arm Description
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Intervention Type
Other
Intervention Name(s)
POHIM-CCRT
Intervention Description
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Primary Outcome Measure Information:
Title
Acute toxicities according to CTCAE v4.0
Description
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Late toxicities according to CTCAE v4.0
Description
evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0
Time Frame
5-years
Title
Progression free survival rate
Description
progression free survival rate after the time of surgery
Time Frame
5-years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Park, M.D.,Ph.D
Phone
+82-10-9933-2616
Email
wonro.park@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Park, M.D.,Ph.D
Phone
+82-2-3410-2616
Email
wonro.park@samsung.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer
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