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Recruiting Phase 3 NCT06641635

NCT06641635 Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

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Clinical Trial Summary
NCT ID NCT06641635
Status Recruiting
Phase Phase 3
Sponsor Peking Union Medical College Hospital
Condition Cervical Cancer
Study Type INTERVENTIONAL
Enrollment 440 participants
Start Date 2024-11-19
Primary Completion 2026-10-31

Trial Parameters

Condition Cervical Cancer
Sponsor Peking Union Medical College Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 440
Sex FEMALE
Min Age 18 Years
Max Age 75 Years
Start Date 2024-11-19
Completion 2026-10-31
Interventions
Moderated hypofractionated online adaptive radiotherapyConventional radiotherapy

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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 availability of medical resources. We hope to assess the safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with brachytherapy in patients with cervical cancer in a multicenter study.

Eligibility Criteria

Inclusion Criteria: 1. The patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment 2. Age ≥18 and ≤75 years 3. FIGO stage IB-IIIB cervical cancer; IIIC1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis) 4. Pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 5. Concurrent weekly cisplatin therapy ± immunotherapy 6. Able to undergo brachytherapy 7. ECOG performance status of 0-1, with an expected ability to tolerate lying flat for half an hour. Exclusion Criteria: 1. Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization 2. FIGO stages IA, IIIC2, IVA, or IVB 3. FIGO stage IIIC1 with lymph nodes \>2 cm, or with common iliac lymph node metastasis 4. History of prior abdominal or pelvic radiotherapy 5. Pregnant or breastfeeding women 6. Patients with active infections or

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