Postoperative intensity-modulated radiation therapy in cervical cancer trial

Postoperative hypofractionated intensity-modulated radiation therapy in cervical cancer: A prospective phase II exploratory trial (POHIM_RT trial)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004700

Enrollment

120

Registered

2020-02-04

Start date

2017-05-31

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

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 necessary.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) histological confirmed cervical cancer 2) radical hysterectomy and pelvic lymph node dissection was done 3) indicated as below in pathology (more than one) - tumor size =4cm - lymphovascular invasion - cervical stromal invasion =1/2 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) If the patient voluntarily completes the consent form

Exclusion criteria

Exclusion criteria: 1) pelvic lymph node metastasis 2) distant metastiss (retroperitoneal lymph node metastasis) 3) resection margin positive 4) parametrial invasion 5) previous pelvic radiohterapy 6 more than 3 months after radical hysterectomy 7 serious acute illness 8 neoadjuvant chemotherapy 9 other cancer history except for thyroid cancer, skin cancer, cervix is situ

Design outcomes

Primary

Measure	Time frame
more than acute grade 3 toxicity	—

Secondary

Measure	Time frame
more than chronic grade 3 toxicity	—

Countries

Korea, Republic of

Contacts

Public ContactKyung Min Kim

Samsung Medical Center

Outcome results