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Recruiting
NCT07684508
Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Cervical Cancer
Conditions: Hypofractionated Radiotherapy, Intensity-modulated Radiotherapy, Cervical Cancers
Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 154
Sponsor: Manni Huang
Location: Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality
Summary
To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07684508). StuddyBuddy aggregates publicly available trial information.