Online Adaptive Radiotherapy for Cervical Cancer

NCT ID: NCT06562166

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ART

Group Type EXPERIMENTAL

online adaptive radiotherapy

Intervention Type RADIATION

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

IGRT

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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online adaptive radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. 18-80 years old;
2. Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
3. 2018 FIGO Stage Ib3, II, IIIB and IIIC1
4. Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)
5. ECOG score 0-2
6. Life expectancy greater than 6 months
7. Ability to remain lying down for more than 30 minutes
8. Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form
9. 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
10. Must complete baseline assessments and investigations required before treatment before enrolment
11. be eligible for regular follow-up

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Jiangsu University

UNKNOWN

Sponsor Role collaborator

Zhongnan Hospital

OTHER

Sponsor Role collaborator

Jingzhou First People's Hospital

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Nanhua University

UNKNOWN

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking union medical college hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuai Sun

Role: CONTACT

15801390180

Facility Contacts

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Shuai Sun

Role: primary

+86-15540101705

Other Identifiers

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ART_cervical cancer

Identifier Type: -

Identifier Source: org_study_id

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