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Recruiting NCT06641635

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

Phase III Interventional Cervical Cancer Adaptive Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Moderated hypofractionated online adaptive radiotherapy, Conventional radiotherapy.
Who it may be relevant to
Registry conditions: Cervical Cancer, Adaptive Radiotherapy. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer

Overview

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.

Detailed description

This is a multicenter, non-inferiority, phase 3, randomized controlled study. This study investigates the role of moderated hypofractionated online adaptive radiotherapy by randomizing patients to this experimental regimen versus the standard of treatment.The purpose of this study is to access safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with high-dose-rate brachytherapy in patients with cervical cancer, which based on the previous research (NCT05994300).

Interventions

  • Combination product 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
  • Combination product 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

Primary outcome measures

  • Progression Free Survival [Time frame: 3 years]
Secondary outcome measures (10)
  • Acute toxicity [Time frame: 3 months]
  • Late toxicity [Time frame: 3 years]
  • Overall survival [Time frame: 3 years]
  • Quality of life (QoL) [Time frame: 3 years]
  • Quality of Life (QoL) [Time frame: 3 years]
  • Locoregional progression-free survival [Time frame: 3 years]
  • Tumor response evaluation Complete remission rate [Time frame: 3 months]
  • Metastasis-free survival [Time frame: 3 years]
  • Cervical cancer-specific survival [Time frame: 3 years]
  • Treatment expense [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Publications

  • 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. PMID 40671096

Identifiers

NCT: NCT06641635 · SWIFT-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗