Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Cervical Cancer

Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Postoperative Cervical Cancer (AMICA-CC) : a Prospective, Multicenter, Phase II Trial

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).

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.