New radiotherapy approach for cervical cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, phase 3, randomized controlled trial evaluates the safety and efficacy of moderated hypofractionated online adaptive radiotherapy combined with high-dose-rate brachytherapy in patients with cervical cancer. Participants will be randomized to receive either this experimental treatment or the conventional radiotherapy regimen. The study aims to determine if the new approach can provide similar or better outcomes while potentially reducing treatment duration and resource utilization. The trial is designed to assess non-inferiority compared to standard treatment protocols.

Why it matters

Who can join: the full rules

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 2018 stage IB1-IIB, 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
2. FIGO stages IA, IIIA, IIIC2, IVA, or IVB
3. FIGO stage IIIC1 with lymph nodes \>2 cm, or with common iliac lymph node metastasis
4. Patients who received other anticancer treatments, including chemotherapy, targeted therapy, or immunotherapy, before concurrent chemoradiotherapy.
5. History of prior abdominal or pelvic radiotherapy
6. Pregnant or breastfeeding women
7. Patients with active infections or fever
8. 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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zheng Zeng, MD.
• Email: zengzheng1206@163.com
• Phone: 86-10-6512-4875

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.