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Clinical Trials in China / NCT05880485
Active, not recruiting Phase 1/2

Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer

NCT05880485 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Phase 1/2
Started
2023-02-02
Last updated
2026-06-08

Condition(s) studied

Uterine Cervical Neoplasm

Investigational drug(s) / intervention(s)

online adaptive radiotherapy

online adaptive radiotherapy: PTV with 5-10 margins covers CTV

Study summary

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for cervical cancer. To explore the value of reduced margins in oART for cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment. 2. Age ≥18 years and ≤ 75 years. 3. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al. 4. No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on CT, MRI or positron emission tomograph (PET)/CT. 5. No contraindications to CT scanning. 6. No evidence of distant metastasis (FIGO stage IVB). 7. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L. 8. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN). Exclusion Criteria: 1. With common iliac MLNs. 2. Tumor extended to the lower third of the vagina. 3. Tumor spread to mucosa of the bladder or rectum. 4. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes. 5. Prior malignancy. 6. History of previous radiotherapy to the abdomen or pelvis. 7. Pregnancy or lactation. 8. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer. 9. Active infection with fever. 10. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted. 11. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality

More Peking Union Medical College Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05880485 on ClinicalTrials.gov ↗ ← All trials in China