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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 18-70 years old;

• Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;

• 2018 FIGO Stage Ib3, II, 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

Locations
Other Locations
China
Peking union medical college hospital
RECRUITING
Beijing
Contact Information
Primary
Shuai Sun
sunshuai@pumch.cn
15801390180
Time Frame
Start Date: 2024-09-05
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 124
Treatments
Experimental: ART
No_intervention: IGRT
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Jiangsu University, Tongji Hospital, Zhongnan Hospital, Jingzhou First People's Hospital, The First Affiliated Hospital of Nanhua University
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov