Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

Samsung Medical Center

Status: Active, not recruiting

Conditions: Hypofractionated Dose; Radiotherapy, Intensity-Modulated; Radiotherapy, Adjuvant; Cervix Cancer

Treatments: Radiation: POHIM-RT

Study type: Interventional

Funder types: Other

Identifiers

NCT03239626

SMC 2017-03-092-002

Details and patient eligibility

About

To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.

Enrollment: 120 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 radiotherapy ( more than one as below)

  1. tumor size ≥4 cm
  2. positive lymphovascular invasion
  3. more than half stromal invasion depth

• ECOG performance status 0 or 1

• Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl

Exclusion criteria

• positive pelvic lymph node metastasis
• positive distant metastasis (including retroperitoneal lymph node metastasis)
• positive tumor involvement on resection margin
• positive parametrial invasion
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

POHIM-RT

Experimental group

Description:

adjuvant hypofractionated IMRT for cervical cancer patients

Treatment:

Radiation: POHIM-RT