Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer
A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer
Peking Union Medical College Hospital
440 participants
Nov 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria7
- 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.
Interventions
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
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
Locations(1)
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NCT06641635