Status:
ACTIVE_NOT_RECRUITING
Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Cervix Cancer
Radiotherapy, Adjuvant
Eligibility:
FEMALE
20-70 years
Phase:
NA
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 fracti...
Eligibility Criteria
Inclusion
- histologically confirmed cervical cancer
- radical hysterectomy and pelvic lymph node dissection was done
- histologically indicated adjuvant radiotherapy ( more than one as below)
- tumor size ≥4 cm
- positive lymphovascular invasion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03239626
Start Date
August 31 2017
End Date
April 28 2025
Last Update
January 3 2025
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351