Online Adaptive Radiotherapy (oART) in Radical Radiotherapy for Cervical Cancer - A Multi-center Randomized Controlled Study

Peking Union Medical College Hospital1 site in 1 country124 target enrollmentSeptember 5, 2024

ConditionsCervical Cancer

Interventionsonline adaptive radiotherapy

Overview

Phase: Phase 2
Intervention: online adaptive radiotherapy
Conditions: Cervical Cancer
Sponsor: Peking Union Medical College Hospital
Enrollment: 124
Locations: 1
Primary Endpoint: Acute non-hematological toxicity
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 5, 2024

End Date

December 1, 2028

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18-80 years old;
•Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
•2018 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

Exclusion Criteria

•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.

Arms & Interventions

ART

Intervention: online adaptive radiotherapy

IGRT

Outcomes

Primary Outcomes

Acute non-hematological toxicity

Time Frame: 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.