To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer
This multicenter, phase II trial was conducted to assess the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in patients with cervical cancer after hysterectomy. The primary endpoint was the incidence of acute grade 3 or higher gastrointestinal (GI), genitourinary (GU), and hematologic toxicities during radiotherapy (RT) or within three months after RT completion, based on the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. The secondary endpoints included late toxicities, scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) / Cervical Cancer Module (CX24), disease-free survival (DFS), and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Postoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGLang Fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences
Langfang, Hebei, China
RECRUITINGAcute toxicities
the incidence of acute grade 3 or higher gastrointestinal (GI), genitourinary (GU), and hematologic toxicities during radiotherapy (RT) or within three months after RT completion, based on the CTCAE version 6.0
Time frame: 3 months
Late toxicities
evaluation of late toxicities during three months to one year after RT completion according to CTCAE version 6.0
Time frame: 1 year
Disease-Free Survival (DFS)
the time from initiation of study treatment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.
Time frame: 2-years
Overall Survival (OS)
the time from the start of study treatment to death from any cause.
Time frame: 2-years
Patient-reported quality of life
scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) / Cervical Cancer Module (EORTC QLQ-CX24).The scale ranges from 0 to 100, where higher scores represent better quality of life.
Time frame: 2-years
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