Cervix Cancer, Chemotherapy, Concurrent, Hypofractionated Dose, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated
Conditions
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.
Interventions
OTHERPOHIM-CCRT
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicities according to CTCAE v4.0 | 3 months | evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed