Status:
RECRUITING
Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Shandong Cancer Hospital and Institute
Conditions:
Cervical Cancer
Adaptive Radiotherapy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The most common external beam radiotherapy fractionation scheme for cervical cancer is 45-50.4 Gy delivered in 25-28 fractions. However, prolonged treatment duration can lead to insufficient availabil...
Detailed Description
This is a multicenter, non-inferiority, phase 3, randomized controlled study. This study investigates the role of moderated hypofractionated online adaptive radiotherapy by randomizing patients to thi...
Eligibility Criteria
Inclusion Criteria:
- The patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment
- Age ≥18 and ≤75 years
- FIGO stage IB-IIIB cervical cancer; IIIC1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis)
- Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Concurrent weekly cisplatin therapy ± immunotherapy
- Able to undergo brachytherapy
- ECOG performance status of 0-1, with an expected ability to tolerate lying flat for half an hour.
Exclusion Criteria:
- Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization
- FIGO stages IA, IIIC2, IVA, or IVB
- FIGO stage IIIC1 with lymph nodes >2 cm, or with common iliac lymph node metastasis
- History of prior abdominal or pelvic radiotherapy
- Pregnant or breastfeeding women
- Patients with active infections or fever
- Other severe diseases that may significantly affect clinical trial compliance, such as unstable heart disease, kidney disease, chronic hepatitis requiring treatment, poorly controlled diabetes, or mental disorders.
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2029
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT06641635
Start Date
November 19 2024
End Date
October 31 2029
Last Update
March 18 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China