Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postoperative Radiotherapy.
- Who it may be relevant to
- Registry conditions: Hypofractionated Radiotherapy, Intensity-modulated Radiotherapy, Cervical Cancers. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Postoperative Cervical Cancer (AMICA-CC) : a Prospective, Multicenter, Phase II Trial
Overview
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
- Radiation Postoperative Radiotherapy
Postoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day)
Primary outcome measures
- Acute toxicities [Time frame: 3 months]
Secondary outcome measures (4)
- Late toxicities [Time frame: 1 year]
- Disease-Free Survival (DFS) [Time frame: 2-years]
- Overall Survival (OS) [Time frame: 2-years]
- Patient-reported quality of life [Time frame: 2-years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
- Lang Fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences — Langfang
Identifiers
NCT: NCT07684508 · NCC6049