uterine cervial cancer uterine cervial cancer
Conditions
Interventions
To add holographic (HGP) image-guided support using Holoeyes MD during brachytherapy, which is part of standard care for cervical cancer.
Sponsors
Murakami Naoya
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with cervical cancer diagnosed pathologically as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 2. Patients aged between 18 and 80 years at the time of obtaining informed consent. 3. Patients with locally advanced cervical cancer without distant metastasis who are eligible for definitive radiotherapy. The presence or absence of regional lymph node metastasis is not a criterion for exclusion, and para-aortic lymph node metastasis is acceptable. However, patients with metastasis to the mediastinal or supraclavicular lymph nodes (cranial to the diaphragm) are excluded. 4. Patients with T1b2 to T4a disease who are candidates for combined intracavitary and interstitial brachytherapy. 5. Patients who are treated with the combination of external beam radiotherapy and brachytherapy. 6. Patients who are able to obtain written informed consent of their own free will.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of pelvic radiation therapy. 2. Patients with a history of surgery for cervical cancer other than conization or laser treatment. 3.Patients currently taking anticoagulant or antiplatelet medications that cannot be discontinued. 4.Patients with active dermatomyositis, systemic lupus erythematosus (SLE), or scleroderma. 5. Patients with distant metastases beyond the pelvis, excluding para-aortic lymph node metastasis. 6. Patients with severe psychiatric disorders or significant cognitive impairment that make it difficult to obtain informed consent. 7. Patients who are unable to assume the lithotomy position due to hip joint disorders or other reasons. 8. Patients with T1a, T1b1, or T2a1 disease who are not candidates for combined intracavitary and interstitial brachytherapy. 9. Pregnant or breastfeeding women. 10. Patients deemed inappropriate for participation in the study by the principal or sub-investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of patients who were able to sign out* without experiencing any adverse events of Grade 3 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE) v5 in all brachytherapy sessions (3-4 sessions). The frequency and proportion will be calculated for each group. Sign-out: Leaving the brachytherapy room. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Average procedure time 2) Percentage of treatments that were signed off without causing grade 3 or higher adverse events 3) Percentage of dose constraints complied with 4) ADS (Adjusted Dose Score, dose superiority) 5) Dose reproducibility 6) Surgeon questionnaire (HGP treatment group only): Surgeon evaluations of the wearability, visibility, operability, and motion sickness of HMD and Holoeyes MD, and surgeon evaluations using the NASA TLX 7) Incidence of diseases, etc. 8) Equipment malfunction status 9) Record adverse events within 30 days after treatment and collect information on the safety of intraoperative complications. Collect the relevant information at Visit 6 (4 weeks after treatment) in the schedule table in 8. Observation and examination items and timing. | — |
Contacts
Public ContactNaoya Murakami
Department of Radiation Oncology, Juntendo University Graduate School of Medicine
Outcome results
None listed