AzTrials
AzTrials

Cervical CancerPhase 3NCT06641635

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

A Phase 3 study testing Moderated hypofractionated online adaptive radiotherapy and Conventional radiotherapy in people with Cervical Cancer and Adaptive Radiotherapy, run by Peking Union Medical College Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer, Adaptive Radiotherapy
What is being tested?
Moderated hypofractionated online adaptive radiotherapy and Conventional radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteChina
Study dates
19 Nov 2024to 31 Oct 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 2018 stage IB1-IIB, 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.

Who cannot join

  • Patients who have undergone cervical cancer surgery
  • FIGO stages IA, IIIA, IIIC2, IVA, or IVB
  • FIGO stage IIIC1 with lymph nodes >2 cm, or with common iliac lymph node metastasis
  • Patients who received other anticancer treatments, including chemotherapy, targeted therapy, or immunotherapy, before concurrent chemoradiotherapy.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zheng Zeng, MD. contact

86-10-6512-4875

zengzheng1206@163.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing

    Junfang Yan, MD, 01069155484, yanjunfang@pumch.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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).

Being tested
Moderated hypofractionated online adaptive radiotherapy, Conventional radiotherapy
Keywords
Cervical Cancer, Moderated Hypofractionated Radiotherapy, Adaptive Radiotherapy, Randomized controlled trial
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moderated hypofractionated online adaptive radiotherapyCombination product

    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 radiotherapyCombination product

    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 groups in NCT06641635
Study groupRoleWhat they receive
Experimental groupExperimentalModerately hypofractionated online adaptive radiotherapy +Concurrent Chemotherapy or Immunotherapy Experimental
Receives: Combination Product: Moderated hypofractionated online adaptive radiotherapy
Control groupActive comparatorConventionally fractionated intensity-modulated radiotherapy +Concurrent Chemotherapy or Immunotherapy Standard of Care
Receives: Combination Product: Conventional radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Defined as time from date of randomization to date of progression, date of death from any cause, or date of last follow-up, whichever occurs first. Cancer progression can be identified during physical exam, biopsy, or imaging of any kind.

    Measured: 3 years

Secondary outcomes (10)

  1. Acute toxicity

    This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.

    Measured: 3 months

  2. Late toxicity

    Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.

    Measured: 3 years

  3. Overall survival

    Defined as time from date of randomization to date of death from any cause, or date of last follow-up, whichever occurs first.

    Measured: 3 years

  4. Quality of life (QoL)

    QoL will evaluated by the EORTC QLQ-C30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent."

    Measured: 3 years

  5. Quality of Life (QoL)

    QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. Acute and late vaginal and sexual QoL will be assessed using the QLQ-CX24 vaginal and sexual domains respectively.

    The QLQ-CX24 responses are regarding function and symptoms of sexual and vagina health. It is based on a scale of 1 (not at all) to 4 (very much).

    Measured: 3 years

  6. Locoregional progression-free survival

    Defined as time from date of randomization to date of locoregional progression, date of death from any cause, or date of last follow-up, whichever occurs first.

    Measured: 3 years

  7. Tumor response evaluation Complete remission rate

    Evaluated with RECIST 1.1

    Measured: 3 months

  8. Metastasis-free survival

    Defined as time from date of randomization to date of development of metastasis, date of death from any cause, or date of last follow-up, whichever occurs first.

    Measured: 3 years

  9. Cervical cancer-specific survival

    Defined as time from date of randomization to date of death attributed to cervical cancer, or date of last-follow-up, whichever occurs first.

    Measured: 3 years

  10. Treatment expense

    The treatment-related costs incurred during the course of treatment.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start19 Nov 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06641635
Sponsor's protocol ID
SWIFT-1
Status last verified
Sep 2026
First submitted
8 Oct 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

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.

    PubMed 40671096

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Moderated hypofractionated online adaptive radiotherapy and Conventional radiotherapy in people with Cervical Cancer and Adaptive Radiotherapy, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zheng Zeng, MD. (86-10-6512-4875, zengzheng1206@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06641635, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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