Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Cervical Cancer

August 3, 2026 updated by: Manni Huang

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 months
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
Time Frame: 1 year
evaluation of late toxicities during three months to one year after RT completion according to CTCAE version 6.0
1 year
Overall Survival (OS)
Time Frame: 2-years
the time from the start of study treatment to death from any cause.
2-years
Disease-Free Survival (DFS)
Time Frame: 2-years
the time from initiation of study treatment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.
2-years
Patient-reported quality of life
Time Frame: 2-years
scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) / Cervical Cancer Module (EORTC QLQ-CX24).The scale ranges from 0 to 100, where higher scores represent better quality of life.
2-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manni Huang

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: MAN NI HUANG, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 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)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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