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Clinical Trials in China / NCT06641635
Recruiting Phase 3

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

NCT06641635 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Phase 3
Started
2024-11-19
Last updated
2025-03-18

Condition(s) studied

Cervical CancerAdaptive Radiotherapy

Investigational drug(s) / intervention(s)

Moderated hypofractionated online adaptive radiotherapyConventional radiotherapy

Moderated hypofractionated online adaptive radiotherapy: Radiation: Moderated hypofractionated online adaptive radiotherapy (oART)+ High-dose rate (HDR) Brachytherapy Experimental group: 43.35Gy/17F external beam radiotherapy with oART + HDR-Brachytherapy Drug: Concurrent Chemotherapy or immunotherapy Weekly cisplatin 40 mg/m2 or PD-1 inhibitors

Conventional radiotherapy: Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Contral group: 45Gy/25F EBRT + HDR-Brachytherapy Drug: Concurrent Chemotherapy or immunotherapy Weekly cisplatin 40 mg/m2 or PD-1 inhibitors

Study 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

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 fever 7. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641635 on ClinicalTrials.gov ↗ ← All trials in China