Status:

RECRUITING

Online Adaptive Radiotherapy for Cervical Cancer

Lead Sponsor:

Peking Union Medical College Hospital

Collaborating Sponsors:

The First Affiliated Hospital of Jiangsu University

Zhongnan Hospital

Conditions:

Cervical Cancer

Eligibility:

FEMALE

18-80 years

Phase:

PHASE2

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, th...

Eligibility Criteria

Inclusion

  • 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
  • be eligible for regular follow-up

Exclusion

  • 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.

Key Trial Info

Start Date :

September 5 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

124 Patients enrolled

Trial Details

Trial ID

NCT06562166

Start Date

September 5 2024

End Date

December 1 2028

Last Update

January 8 2026

Active Locations (1)

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Peking union medical college hospital

Beijing, China, 100730