NCT06562166

Brief Summary

This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
32mo left

Started Sep 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Sep 2024Dec 2028

First Submitted

Initial submission to the registry

August 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

September 5, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 8, 2026

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

August 16, 2024

Last Update Submit

January 7, 2026

Conditions

Cervical Cancer

Keywords

cervical canceradaptive radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Acute non-hematological toxicity

    Acute non-hematologic toxicities include gastrointestinal and genitourinary toxicities, which will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    From the start of treatment until 3 months later

Secondary Outcomes (1)

  • treatment response

    3 months after completion of treatment

Study Arms (2)

ART

EXPERIMENTAL
Radiation: online adaptive radiotherapy

IGRT

NO INTERVENTION

Interventions

online adaptive radiotherapyRADIATION

Patients in ART group received daily online adaptive radiotherapy with a prescription dose of 50.4Gy/28f.

ART

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old;
  • Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
  • FIGO Stage Ib3, II, IIIB and IIIC1
  • Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)
  • ECOG score 0-2
  • Life expectancy greater than 6 months
  • Ability to remain lying down for more than 30 minutes
  • Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form
  • Complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: NEUT ≥ 1.5\*109/L, HGB ≥ 60g/L, platelets ≥ 100×109/, blood creatinine \<1.5 mg/dL. AST and ALT are within 2 times the upper limit of normal
  • Must complete baseline assessments and investigations required before treatment before enrolment
  • be eligible for regular follow-up

You may not qualify if:

  • Have received radiotherapy or chemotherapy in the past
  • Have undergone radical surgery for cervical cancer
  • Have a previous history of malignant tumor
  • Pregnant or lactating women
  • Presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Shuai Sun

CONTACT

15801390180sunshuai@pumch.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 20, 2024

Study Start

September 5, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

January 8, 2026

Record last verified: 2025-02

Locations

CN(1)