Postoperative intensity-modulated radiation therapy with concurrent chemotherapy in cervical cancer trial

Postoperative hypofractionated intensity-modulated radiation therapy with concurrent chemotherapy in cervical cancer: A prospective phase II exploratory trial (POHIM_CCRT trial)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004702

Enrollment

Registered

2020-02-04

Start date

2017-04-29

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery, Radiation : Radiation therapy is delivered 16 intensity-controlled radiation treatments for three to four weeks. After external radiation therapy, brachytherapy can also be added if

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: ) histologicall confirmed cervical cancer 2) radical hysterectomy and pelvic lymph node dissection was done 3) indicated as below in pathology (more than one) - pelvic lymph node metastasis - parametrial involvement - resection margin positive 4) age 20-70 5) ECOG 0-1 6) granulocyte =1.0 x 103/µl, platelet =30 x 103/µl, hemoglobin =10 g/dl 7) creatinine <2.0 mg/dL, bilirubin 1.5 mg/dl 8) If the patient voluntarily completes the consent form

Exclusion criteria

Exclusion criteria: 1) distant metastiss (retroperitoneal lymph node metastasis) 2) previous pelvic radiohterapy 3) more than 3 months after radical hysterectomy 4) serious acute illness 5) neoadjuvant chemotherapy 6) radiotherapy alone patient 7) other cancer history except for thyroid cancer, skin cancer, cervix is situ

Design outcomes

Primary

Measure	Time frame
more than acute grade 3 toxicities	—

Secondary

Measure	Time frame
more than chronic grade 3 toxicities	—

Countries

Korea, Republic of

Contacts

Public ContactKyung Min Park

Samsung Medical Center

Outcome results