Clinical trial · Interventional
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
NCT07684508CI-TRIAL-00120740recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Hypofractionated Radiotherapy | — | UNRESOLVED | — |
| Intensity-modulated Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Postoperative Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Postoperative Radiotherapy
- description
- Patients undergo moderately hypofractionated IMRT after radical hysterectomy
- interventionNames
- Radiation: Postoperative Radiotherapy
Primary outcomes (1)
- measure
- Acute toxicities
- timeFrame
- 3 months
- description
- 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 outcomes (4)
- measure
- Late toxicities
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.