New radiotherapy approach for cervical cancer treatment
A Multicenter, Non-inferiority, Phase 3, Randomized Controlled Study of Moderated Hypofractionated Online Adaptive Radiotherapy for Cervical Cancer
PHASE3 · Peking Union Medical College Hospital · NCT06641635
This study is testing a new type of radiation treatment for cervical cancer to see if it works as well as the standard treatment while possibly taking less time.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06641635 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 with FIGO stage IB-IIIB cervical cancer and specific histological types who can tolerate the treatment regimen.
Not a fit: Patients with advanced stages of cervical cancer, prior abdominal or pelvic radiotherapy, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more efficient treatment for cervical cancer, improving patient outcomes and resource management.
How similar studies have performed: Previous studies have shown promise with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Zheng Zeng, MD.
- Email: zengzheng1206@163.com
- Phone: 86-10-6512-4875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Cancer, Adaptive Radiotherapy, Moderated Hypofractionated Radiotherapy, Randomized controlled trial