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

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancers; Intensity-modulated Radiotherapy; Hypofractionated Radiotherapy
• Intervention / Treatment: Radiation: Postoperative Radiotherapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MAN NI HUANG, MD; Phone Number: 8610-87788495; Email: huangmanni@csco.ac.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital, Chinese Academy of Medical Sciences
      • Contact: MAN NI HUANG, MD; Phone Number: 8610-87788495; Email: huangmanni@csco.ac.cn
      • Principal Investigator: MAN NI HUANG, MD
  • Hebei
    • Langfang, Hebei, China, 065001
      • Recruiting
      • Lang Fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences
      • Contact: JU SHENG AN, MD; Phone Number: 0316-5918495
      • Principal Investigator: JU SHENG AN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postoperative Radiotherapy; Patients undergo moderately hypofractionated IMRT after radical hysterectomy	Radiation: Postoperative Radiotherapy; Postoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute toxicities	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late toxicities	evaluation of late toxicities during three months to one year after RT completion according to CTCAE version 6.0	1 year
Disease-Free Survival（DFS）	the time from initiation of study treatment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.	2-years
Overall Survival (OS)	the time from the start of study treatment to death from any cause.	2-years
Patient-reported quality of life	scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) / Cervical Cancer Module (CX24)	2-years

Collaborators and Investigators

• Sponsor: Manni Huang

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: NCC6049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No