Cervical Cancers, Hypofractionated Radiotherapy, Intensity-modulated Radiotherapy
Conditions
Brief summary
To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer
Detailed description
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).
Interventions
RADIATIONPostoperative Radiotherapy
Postoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day)
Sponsors
Manni Huang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ECOG performance status 0 or 1; * Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; * Status post radical hysterectomy with pelvic lymph node dissection with or without para-aortic lymph node dissection, and postoperative radiotherapy initiated within 3 months; * For squamous cell carcinoma: meeting Sedlis criteria; for adenocarcinoma and adenosquamous carcinoma: meeting the "four-factor model"; * Bone marrow function: white blood cell (WBC) count ≥3.0×10⁹/L, neutrophil count (NEUT) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin (Hb) ≥90 g/L; renal function: normal or serum creatinine (SCr) ≤1.5×upper limit of normal (ULN) or creatinine clearance ≥50 ml/min; hepatic function: total bilirubin (TBIL) ≤1.5×ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5×ULN; * Voluntarily signed the informed consent form prior to study enrollment.
Exclusion criteria
* History of active malignant tumor within 3 years prior to initial treatment（except for the cervical cancer）and any locally curable tumors treated with radical therapy; * Any high-risk factor confirmed by postoperative pathology: positive lymph node metastasis, positive parametrial invasion, or positive resection margin; * History of neoadjuvant therapy prior to enrollment; * Local recurrence or distant metastasis prior to enrollment; * Postoperative intestinal obstruction or intestinal adhesion; * Severe cardiac, cerebral, hepatic, or renal disorders; * Long-term immunocompromised state; * Pregnant or lactating females; * Premature discontinuation of treatment for any reason; * Poor compliance, unwillingness to participate, or inability to cooperate with follow-up; * Any other conditions deemed unsuitable for this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicities | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late toxicities | 1 year | evaluation of late toxicities during three months to one year after RT completion according to CTCAE version 6.0 |
| Disease-Free Survival（DFS） | 2-years | the time from initiation of study treatment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause. |
| Overall Survival (OS) | 2-years | the time from the start of study treatment to death from any cause. |
| Patient-reported quality of life | 2-years | scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) / Cervical Cancer Module (CX24) |
Countries
China
Contacts
CONTACTMAN NI HUANG, MD
Outcome results
None listed