RecruitingPhase 2NCT06562166

Online Adaptive Radiotherapy for Cervical Cancer

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


Sponsor

Peking Union Medical College Hospital

Enrollment

124 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria11

  • 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

Exclusion Criteria5

  • 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.

Interventions

RADIATIONonline adaptive radiotherapy

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


Locations(1)

Peking union medical college hospital

Beijing, China

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NCT06562166


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