Moderately hypofractionated radiotherapy after hysterectomy for cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter phase II trial evaluates the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy administered after radical hysterectomy with lymph node assessment. The primary endpoint is the rate of acute severe (grade 3+) GI, GU, or hematologic toxicities during treatment or within three months after completion. Secondary endpoints include late toxicities, quality of life measures, disease-free survival, and overall survival. Eligible participants have postoperative cervical cancer with specific histologies and adequate organ function, and must have begun radiotherapy within three months of surgery. The trial is sponsored by Manni Huang with participation from the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, at Beijing and Langfang locations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Lang Fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences
  Langfang, Hebei, China Recruiting

Study contacts

• Principal investigator: Man Ni Huang, Md — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Man Ni Huang, Md
• Email: huangmanni@csco.ac.cn
• Phone: 8610-87788495

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.