Hypofractionated RadiotherapyNCT07684508
Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Cervical Cancer
A study testing Postoperative Radiotherapy in people with Hypofractionated Radiotherapy and Intensity-modulated Radiotherapy, run by Manni Huang at 2 sites in China.
Trial summary
To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Hypofractionated Radiotherapy, Intensity-modulated Radiotherapy, Cervical Cancers
- What is being tested?
- Postoperative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jul 2026to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
MAN NI HUANG, MD, 8610-87788495, huangmanni@csco.ac.cn
MAN NI HUANG, MD
- Recruiting
Lang Fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences
Langfang, Hebei, 065001
JU SHENG AN, MD, 0316-5918495
JU SHENG AN, MD
About this study
Official title: 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
Read the 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).
- Being tested
- Postoperative Radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative RadiotherapyRadiation
Postoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day)
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Radiotherapy | Experimental | Patients undergo moderately hypofractionated IMRT after radical hysterectomy Receives: Radiation: Postoperative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
Late toxicities
evaluation of late toxicities during three months to one year after RT completion according to CTCAE version 6.0
Measured: 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.
Measured: 2-years
Overall Survival (OS)
the time from the start of study treatment to death from any cause.
Measured: 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 (EORTC QLQ-CX24).The scale ranges from 0 to 100, where higher scores represent better quality of life.
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start10 Jul 2026
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypofractionated RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manni Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manni Huang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- MAN NI HUANG, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684508
- Sponsor's protocol ID
- NCC6049
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Postoperative Cervical Cancer (AMICA-CC) : a Prospective, Multicenter, Phase II Trial
- ClinicalTrials.gov ID
- NCT07684508
- Acronym / sponsor ID
- NCC6049
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Manni HuangUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative Radiotherapy | Experimental | Radiation: Postoperative RadiotherapyPatients undergo moderately hypofractionated IMRT after radical hysterectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative RadiotherapyPostoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day) | Radiation | Postoperative Radiotherapy |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MAN NI HUANG, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Radiotherapy in people with Hypofractionated Radiotherapy and Intensity-modulated Radiotherapy, run by Manni Huang at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MAN NI HUANG, MD (8610-87788495, huangmanni@csco.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicities (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.