Actively Recruiting

Phase 3
Age: 18Years - 75Years
FEMALE
ID06641635

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

Led by Peking Union Medical College Hospital · Updated on 2025-03-18

440

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

P

Peking Union Medical College Hospital

Lead Sponsor

P

Peking University Cancer Hospital & Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating moderated hypofractionated online adaptive radiotherapy combined with high-dose-rate brachytherapy in patients with cervical cancer. This multicenter, phase 3, randomized controlled study aims to compare this experimental treatment's safety and efficacy against the standard radiotherapy regimen. The study focuses on women aged 18 to 75 years with specific stages of cervical cancer and examines how this approach may reduce treatment duration and resource usage. Participants are randomly assigned to receive either the experimental treatment, which includes 43.35 Gy of external beam radiotherapy delivered in 17 fractions with online adaptive radiotherapy plus high-dose-rate brachytherapy and concurrent weekly chemotherapy or immunotherapy, or the standard treatment of 45 Gy external beam radiotherapy in 25 fractions with brachytherapy and concurrent chemotherapy or immunotherapy. Both groups receive weekly cisplatin or PD-1 inhibitors, and the study evaluates treatment over a defined period. Throughout the study, participants will be closely monitored for various outcomes including progression-free survival at 3 years, acute and late toxicities, overall survival, quality of life, tumor response, and treatment costs. Assessments include clinical evaluations and quality of life questionnaires over 3 years. The trial will also track locoregional progression, metastasis-free survival, and cervical cancer-specific survival. Safety and adherence will be carefully observed to understand the impact of the treatment regimens.

CONDITIONS

Brief Title

Moderated Hypofractionated Online Adaptive Radiotherapy in Cervical Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient voluntarily consents to participate at least 30 days before enrollment
  • Age between 18 and 75 years
  • Diagnosed with FIGO stage IB-IIIB cervical cancer or stage IIIC1 with limited lymph node metastasis
  • Pathological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
  • Receiving concurrent weekly cisplatin chemotherapy with or without immunotherapy
  • Able to undergo brachytherapy
  • ECOG performance status of 0-1 and able to lie flat for 30 minutes
Not Eligible

You will not qualify if you...

  • Previous cervical cancer surgery except pelvic lymphadenectomy, pelvic lymph node dissection, or cervical conization
  • FIGO stages IA, IIIC2, IVA, or IVB
  • Stage IIIC1 with lymph nodes larger than 2 cm or common iliac lymph node metastasis
  • Prior abdominal or pelvic radiotherapy
  • Pregnant or breastfeeding
  • Active infections or fever
  • Severe diseases affecting trial compliance such as unstable heart disease, kidney disease, chronic hepatitis requiring treatment, poorly controlled diabetes, or mental disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3 to 5 weeks of radiotherapy plus concurrent chemotherapy or immunotherapy

Participants receive moderated hypofractionated online adaptive radiotherapy or conventional radiotherapy combined with high-dose rate brachytherapy and concurrent weekly chemotherapy or immunotherapy.

Weekly visits during radiotherapy

Follow-up

Duration - Up to 3 years

Participants are monitored for safety, tumor response, and quality of life after completing treatment.

Regular visits for assessments over 3 years

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China

Actively Recruiting

Loading map...

Research Team

Z

Zheng Zeng, MD.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Phase 1/2a Study of the Safety, Tolerability, and Prelimin...

Castration-Resistant Prostate Cancer (CRPC)

Actively Recruiting

4 locations

Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for...

Clear Cell Renal Cell Cancer (ccRCC)

Actively Recruiting

1 location

A Phase 1/2 Open Label, Dose Escalation and Expansion Study ...

Advanced Solid Tumor

Actively Recruiting

27 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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.

Zheng Zeng, Yining Chen, Jie Qiu...

https://pubmed.ncbi.nlm.nih.gov/40671096