Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adaptive Radiotherapy | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional radiotherapy | Combination Product | — | UNRESOLVED |
| Moderated hypofractionated online adaptive radiotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Radiotherapy +Concurrent Chemotherapy or Immunotherapy Experimental
- interventionNames
- Combination Product: Moderated hypofractionated online adaptive radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Radiotherapy +Concurrent Chemotherapy or Immunotherapy Standard of Care
- interventionNames
- Combination Product: Conventional radiotherapy
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZeng 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. PMID 40671096