Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer
NCT ID: NCT06641635
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
440 participants
INTERVENTIONAL
2024-11-19
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
Radiotherapy +Concurrent Chemotherapy or Immunotherapy Experimental
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
Control group
Radiotherapy +Concurrent Chemotherapy or Immunotherapy Standard of Care
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Shandong Cancer Hospital and Institute
OTHER
Ruijin Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Zeng Z, Chen Y, Qiu J, Yang B, Wang Z, Meng X, Sun Y, Yan J, Hu K, Zhang F. Moderately hypofractionated online adaptive radiotherapy (SWIFT-1) in cervical cancer patients: study protocol for a multi-centered, open-label, two-arm, phase III, randomized controlled study. Radiat Oncol. 2025 Jul 16;20(1):112. doi: 10.1186/s13014-025-02688-7.
Other Identifiers
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SWIFT-1
Identifier Type: -
Identifier Source: org_study_id
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