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

Study Overview
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Brief Summary
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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.

Official Title
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Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Exploratory Trial (POHIM_CCRT Trial)

Conditions
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Cervix Cancer, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Hypofractionated Dose, Chemotherapy, Concurrent

Intervention / Treatment
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* Other: POHIM-CCRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: POHIM-CCRT<br>postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day) | Other: POHIM-CCRT<br>* postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicities according to CTCAE v4.0 | evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicities according to CTCAE v4.0 | evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0 | 5-years | 
| Progression free survival rate | progression free survival rate after the time of surgery | 5-years |