Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer

Samsung Medical Center

Status

Completed

Conditions

Hypofractionated Dose

Chemotherapy, Concurrent

Radiotherapy, Intensity-Modulated

Radiotherapy, Adjuvant

Cervix Cancer

Treatments

Other: POHIM-CCRT

Study type

Interventional

Funder types

Other

Identifiers

NCT03239613

SMC 2017-03-091-003

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

Female

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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