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Completed

NCT Number: NCT03239613

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

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.

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Key information

Conditions

Cervix Cancer Chemotherapy, Concurrent Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hypofractionated Dose Neoplasms Neoplasms by Site Radiotherapy, Adjuvant Radiotherapy, Intensity-Modulated Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POHIM-CCRT

Other

postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)

Primary outcomes

  1. Acute toxicities according to CTCAE v4.0

    Time frame: 3 months

    evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0

Secondary outcomes

  1. Late toxicities according to CTCAE v4.0

    Time frame: 5-years

    evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0

  2. Progression free survival rate

    Time frame: 5-years

    progression free survival rate after the time of surgery

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2017
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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