Online Adaptive Radiotherapy for Cervical Cancer

Phase 2

Recruiting

• Conditions: Cervical Cancer
• Interventions: Radiation: online adaptive radiotherapy

• Registration Number: NCT06562166
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-20
• Study Start: 2024-09-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-12-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

1. 18-70 years old;
2. Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
3. 2018 FIGO Stage Ib3, II, 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ART	online adaptive radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Acute non-hematological toxicity	From the start of treatment until 3 months later	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.

Secondary Outcome Measures

Name	Time	Method
treatment response	3 months after completion of treatment	Treatment response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, China