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

Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_CCRT Trial)

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.

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