Adjuvant Moderately Hypofractionated Intensity-modulated Radiotherapy for Cervical Cancer

NCT07684508 | Recruiting DMC

• 1 other identifier: NCC6049
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

To investigate the safety and efficacy of moderately hypofractionated intensity-modulated radiotherapy in the treatment of postoperative cervical cancer

Conditions

Intensity-modulated Radiotherapy; Cervical Cancers; Hypofractionated Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Late toxicities

  1 year

• Disease-Free Survival（DFS）

  2-years

• Overall Survival (OS)

  2-years

• Patient-reported quality of life

  2-years

Study Arms (1)

Postoperative Radiotherapy

EXPERIMENTAL

Patients undergo moderately hypofractionated IMRT after radical hysterectomy

Radiation: Postoperative Radiotherapy

Interventions

Postoperative Radiotherapy RADIATION

Postoperative moderately hypofractionated IMRT (2.5Gy per fraction, 17 fractions, once a day)

Postoperative Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manni Huang: lead

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Lang Fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences

Langfang, Hebei, 065001, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

MAN NI HUANG, MD

CONTACT

8610-87788495; huangmanni@csco.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)