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A study of moderate dose online adaptive radiotherapy in cervical cancer

A multicenter, non-inferiority, phase 3, randomized controlled study of moderated hypofractionated online adaptive radiotherapy for cervical cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098353
Enrollment
Unknown
Registered
2025-03-06
Start date
2024-12-19
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

experimental group:Moderately hypofractionated online adaptive radiotherapy.

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients must be fully voluntary and autonomous, having signed an informed consent form within 30 days prior to enrollment; 2.Aged >=18 years 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 ± 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

Exclusion criteria: 1.Patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy/lymph node dissection or cervical conization; 2.FIGO stage IA, IIIC2, IVA, or IVB; 3.FIGO stage IIIC1 with lymph nodes >2 cm or common iliac lymph node metastasis; 4.History of previous abdominal or pelvic radiotherapy; 5.Pregnant or breastfeeding women; 6.Active infection with fever; 7.Other severe diseases that may significantly affect compliance with the clinical trial, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes, or mental illness;

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival;

Secondary

MeasureTime frame
Clinical Complete Response;Overall Survival;Disease-Free Survival;Local Control Rate;Acute or chronic side effects;Quality of Life;Treatment cost;

Countries

China

Contacts

Public ContactFuquan Zhang

Peking Union Medical College Hospital

zhangfuquan3@126.com+86 10 65295483

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026