Comparing Conventional and Hypofractionated Radiation Therapy with Chemotherapy After Cervical Cancer Surgery: A Prospective Multicenter Phase 3 Study
- Conditions
- Neoplasms
- Registration Number
- KCT0009607
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 284
(1) Histologically confirmed cervical cancer
(2) Histologically confirmed Squamous cell carcinoma, Adenocarcinoma or Adenosquamous carcinoma
(3) Patients who underwent radical hysterectomy and pelvic lymph node dissection
(4) Patients with pathological indications for radiotherapy
A. Pelvic lymph node metastasis
B.Parametrium involvement
C.Positive surgical margins
(5) Age 20 - 75 years
(6) ECOG performance status 0-1
(7) Adequate bone marrow function: Granulocytes =1.0 x 103/µl, Platelets =30 x 103/µl, Hemoglobin =9.5 g/dl
(8) Adequate renal and liver function (Creatinine <2.0 mg/dL, Bilirubin 1.5 mg/dl)
(9) Signed informed consent
(1) Distant metastasis
(2) Previous pelvic radiotherapy
(3) More than 3 Months post-radical hysterectomy
(4) Untreated serious acute disease without Cervical cancer
(5) Nooadjuvant chemotherapy
(6) Inability to undergo concurrent chemoradiotherapy
(7) History of other cancer within 5 years (except for thyroid cancer, skin cancer, carcinoma in situ)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method